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Intervention Review

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Surgical versus endoscopic treatment of bile duct stones

  1. Bobby VM Dasari1,*,
  2. Chuan Jin Tan1,
  3. Kurinchi Selvan Gurusamy2,
  4. David J Martin3,
  5. Gareth Kirk1,
  6. Lloyd McKie1,
  7. Tom Diamond1,
  8. Mark A Taylor1

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 3 SEP 2013

Assessed as up-to-date: 1 MAY 2013

DOI: 10.1002/14651858.CD003327.pub3


How to Cite

Dasari BVM, Tan CJ, Gurusamy KS, Martin DJ, Kirk G, McKie L, Diamond T, Taylor MA. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD003327. DOI: 10.1002/14651858.CD003327.pub3.

Author Information

  1. 1

    Mater Hospital/Belfast Health and Social Care Trust, General and Hepatobiliary Surgery, Belfast, Northern Ireland, UK

  2. 2

    Royal Free Campus, UCL Medical School, Department of Surgery, London, UK

  3. 3

    Royal Prince Alfred, Concord & Strathfield Private Hospitals, Sydney, NSW, Australia

*Bobby VM Dasari, General and Hepatobiliary Surgery, Mater Hospital/Belfast Health and Social Care Trust, 15 Boulevard, Wellington Square, Belfast, Northern Ireland, BT7 3LW, UK. bobby.dasari@yahoo.com.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 3 SEP 2013

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This is not the most recent version of the article. View current version (12 DEC 2013)

 
Characteristics of included studies [ordered by study ID]
Bansal 2010

MethodsRandomised trial.

LC + CBDE vs pre-operative ERCP +LC.

Drop-outs or protocol violations reported.

Sample size calculation: no.


ParticipantsAll India Institute of Medical Sciences, India.

July 2007 to April 2008.

Mean age: Group I: 47.1 yrs vs Group II 39.07 yrs.

Pre-operative confirmation of CBD stones: EUS or MRCP.

CBD more than 10 mm size.


InterventionsGr I: LC + LCBDE (15 pts).

Gr II: pre-operative ERCP + LC 4 - 6 weeks later (15 pts).


OutcomesCBD clearance, bleeding, bile leak, pancreatitis, average hospital stay, pain scores (VAS).


NotesCholedochoscopy performed.

T-tube placed after lap CBD exploration.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random number sequences.

Allocation concealment (selection bias)Low riskConcealed envelopes with block randomisation design.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskAll outcomes were clearly defined and reported.

Incomplete outcome dataHigh riskMissing pts were not accounted.

For-profit biasLow riskNone.

Other biasLow riskNone.

Bornman 1992

MethodsRandomised trial of pre-operative ERCP versus open cholecystectomy & cholangiogram with or without CBD exploration.

Drop-outs or protocol violations reported.

Time period: not stated.

Sample size calculation: no.


ParticipantsCape Town. South Africa.

110 pts randomised.

Pts enrolled between October 1989 and January 1992.

172 screened and 62 excluded - reasons stated.

Inclusion criteria: surgically fit pts with gallbladder stones and suspected CBD stones on US or biochemistry.


InterventionsGroup 1: 62 pts.
Pre-operative ERCP/ES and open surgery including subtotal cholecystectomy with or without cholangiogram and bile duct surgery where necessary.

Group 2: 58 pts.
Open cholecystectomy and cholangiogram with or without CBD exploration.

Bile duct surgery in Group 2 also included: choledocho-duodenostomies in 5 and transduodenal sphincteroplasty in 2.


OutcomesSuccessful clearance, bile leak, postoperative death, morbidity, duration of procedure, post-procedural hospital stay.


NotesFirst 90 pts. Published as abstract.

Updated data received on request from author.

Manuscript in provisional form with some specifics in data tables and text unclear.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers.

Allocation concealment (selection bias)Unclear riskUnclear.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Unclear riskUnclear.

Incomplete outcome dataUnclear riskUnclear.

For-profit biasUnclear riskUnclear.

Other biasUnclear riskUnclear.

Cuschieri 1999

MethodsMulticentre randomised trial comparing pre-operative ERC/ES and stone extraction followed by LC versus LC +/- laparoscopic stone extraction.

Adequate report of protocol violations and drop-outs.

Sample size calculations: yes.


ParticipantsInternational trial based in Dundee. UK.

Study commenced 1994, completed August 1997.

300 pts randomised.

Inclusion criteria: ASA I or II.
Ductal stones proven or suspected on clinical (jaundice, recent pancreatitis), biochemical (raised LFTs), or US findings.

Essential investigations:
LFTs, US.

Optional investigations: IVC, CT.


InterventionsGroup 1:

136/150 received correct treatment:

Pre-operative ERCP +/- ES and stone extraction when found. Subsequent laparoscopic cholecystectomy. IOC left to discretion of surgeon.

Group 2:

133/150 received correct treatment:

Laparoscopic cholecystectomy.
IOC in all cases. Laparoscopic stone extraction attempted when stones found.


OutcomesMortality, morbidity, hospital stay.


Notes10% protocol violations.
Pts in Group 1 could have had more than one pre-operative attempt at ERCP.

In Group 2 conversions to open surgery treated as successful clearance.

Transcystic CBDE was performed for small non-occluding stones and transcholedochal CBDE was performed for large or occluding stones.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation was by a random number generator.

Allocation concealment (selection bias)Unclear riskTrial was described as randomised, but the method used to conceal the allocation was not described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskAll outcomes were clearly defined and reported.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Hammarstrom 1995

MethodsRandomised clinical trial comparing ERCP/ES and stone removal versus open surgery alone for pts found to have CBDS proven on ERCP, intravenous cholangiogram, or USS, with an intact gallbladder.
Drop-outs: 3 (all in surgery arm); 2 refused operation, 1 missing set of notes.

Follow-up: Median 92 (63 to 113) months Group 1, 82 (60 to 113) months Group 2.

Sample size calculations: no.


ParticipantsTrial from Sweden.

Commenced Sept 1984, completed Jan 1989, but with 5-year follow-up data.

83 pts randomised.

Inclusion criteria:
CBDS found either on ERC, USS or IVC, intact gallbladder, age < 85 yrs (arbitrary), informed consent.

Exclusion criteria:
Previous B2 anastomosis, malignancy, perforated cholecystitis, unfit for surgery.


InterventionsGroup 1 (ERCP/ES):
Proceeded to ES and stone extraction by a variety of means (basket, balloon, mechanical lithotriptor). Subsequent surgery only if ongoing biliary symptoms.

Group 2 (Surgery):
Open cholecystectomy and ECBD on next available list.
T-tube always used.
Choledochoscopy optional.


OutcomesSuccessful stone clearance, additional endoscopic procedures, median hospital stay, complications - bile leak, gastric retention, duodenal injury after surgery, biliary colic (no surgery), pancreatitis (no surgery), re-operation for bleeding, bile duct injuries, late complications: incisional hernia, retained stone.


NotesSurgery arm all had ERCP to diagnose CBD stones.

Unclear if surgery for late symptoms was included in complication assessment.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskAll outcomes were clearly defined and reported.

Incomplete outcome dataUnclear riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Hong 2006

MethodsRandomised clinical trial.

LC + LCBDE vs LC + intra-operative ERCP.

Sample size estimation: No.

Follow-up: not mentioned.


ParticipantsMedical College of Zhejiang University, People's Republic of China
January 2002 to December 2003.

LC+CBDE: 141 pts.

LC + intra-operative ERCP: 93 pts.

Confirmation: USS/MRCP/IOC.

Inclusion criteria: History, examination, USS, MRCP or cholangiogram. USS was positive in 174 pts, MRCP was positive in 3 and 57 had positive intra- operative cholangiogram.

Exclusion criteria: none mentioned.


InterventionsPrimary closure of CBD using 3'0 Vicryl in 45 cases and T-tube placement in 96 cases.

A second cholangiogram was performed to ensure an unobstructed CBD stone.


OutcomesSuccess rates, surgical time, postoperative hospital stay, hospital charges, complications.


NotesERCP - small stones of 5 - 8mm size were cleared by saline irrigation, larger stones by basket/balloon catheter. Sphincterotomy and lithotriptor were used only for stones larger than 15mm.

Transcystic extraction for smaller stones and transcholedochal extraction for larger stones were performed.

T-tube was used in 96 cases and primary closure of CBD was performed in 46 pts.

Cholangioscope was used.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandomised according to their identification numbers.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskAll outcomes were clearly defined and reported.

Incomplete outcome dataLow riskNo missing data

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Kapoor 1996

MethodsRandomised clinical trial of pts with CBD stones found at ERCP randomised to either ERCP/ES and extraction followed by open cholecystectomy (ES + S group), or open cholecystectomy and CBDE (Surgery group).
Single centre.
Drop-outs: ES + S group - 2 failures to complete treatment, 1 carcinoma of gallbladder; SA group 1 carcinoma of gallbladder.

Sample size calculations: no.

Exclusions: unfit (1), cholangitis (9), unable to perform ERCP (3), large stone (12), no stone (2).


ParticipantsLucknow, India.

Commenced July 1991 and completed October 1993.

33 pts randomised.

Inclusion criteria:
Pts proven to have CBD stones at ERCP, i.e, ERCP achieved. Fit for surgery.

Exclusion criteria:
Pregnancy, cholangitis/septicaemia, CBD cannulation failed at ERCP, stone larger than 15 mm.

Essential investigations:
USS, serum biochemistry.

420 pts seen with gallstones, 60 suspected of having BDS (bilirubin > 34.2 umol/l, ALP > 235 IU/l, CBD diameter > 10 mm or BDS on USS), all underwent ERCP.


InterventionsES + S group:
CBD cleared at time of ERCP by basket or spontaneous passage.
Subsequent surgery scheduled within 6 weeks.

SA group:
Following ERCP, surgery undertaken on next available elective list.
Choledochoscopy optional.


OutcomesMortality, morbidity, clearance rates, hospital stay.


Notes"good risk" pt not defined.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random assignments.

Allocation concealment (selection bias)Low riskSealed envelopes.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for--profit support.

Other biasLow riskNone.

Nathanson 2005

MethodsRandomised clinical trial.
Randomisation of pts with CBS at laparoscopic cholecystectomy after failed transcystic clearance to laparoscopic choledochotomy or postoperative ERCP.

Follow-up: no drop-outs reported.

Time period not stated.

Trial closed prior to reaching original sample size calculations due to slow accrual.


ParticipantsBrisbane. Australia.

Commenced June 1998 and completed October 2003.

86 pts randomised.
(286 pts had successful laparoscopic transcystic stone clearance from a total of 372 pts).
Exclusion criteria:
ERCP prior to referral for LC.
CBD diameter less than 7 mm at LC or if bilioenteric drainage required at same time.


Interventions41 pts randomised to laparoscopic choledochotomy with or without biliary drainage with T-tube or stent.

45 pts randomised to postoperative ERCP during same admission.


OutcomesMortality, morbidity, bile leak, stone clearance rates, re-operation rate, hospital stay.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised.

Allocation concealment (selection bias)Low riskPhone call to the trial centre available 24 hours a day.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo significant missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Neoptolemos 1987

MethodsRandomised trial of pts found at ERCP, USS, or PTC to have CBDS, with intact gallbladder and fit for surgery; randomised to either ES and endoscopic extraction followed by OC or OC + CBDE.

Single centre.

Follow-up:
Drop-outs: 1 pt in Group 2 who had an MI after ERCP and deemed unfit for surgery; 5 pts in Group 1 refused surgery after endoscopic CBDS extraction - these latter were included in results on intention-to-treat analyses.

Sample size calculations: yes.
Based on reduction in morbidity from 40% in the surgical group (Group 2) to 20% in the endoscopic group (Group 1), requiring 79 pts in each group (a = 0.05, b = 0.2).


ParticipantsLeicester Royal Infirmary, UK

Commenced April 1981 and completed December 1985.

120 pts entered based on the finding of CBD stones at ERCP (113), USS (6), or PTC (1).

5 early withdrawals pre-treatment, not available for analysis.

Inclusion criteria:
CBDS found on ERCP, USS or PTC, intact gallbladder, fit for surgery, consent.

Exclusion criteria:
Pregnant.

NB: Cholangitis and jaundice not exclusions.


InterventionsGroup 1:
ES and clearance performed at same time as diagnostic ERCP (if performed), or else on next available list.
OC performed on next available operating list.

Group 2:
OC performed on next available operating list.

Both ES and OC covered with prophylactic antibiotic cefazolin 1 g IV/IM unless cholangitic, in which case penicillin/gentamycin/metronidazole given.


OutcomesMortality, morbidity, endoscopic clearance rates, retained stones, median total hospital stay.


NotesStudy treated as pilot, with termination before calculated optimal numbers recruited, based on there being no likelihood of reaching significance.
Note authors claim that endoscopic clearance was 91%, but should be 87%, since 2 pts developed interval BDS.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone

Noble 2009

MethodsES followed by LC (Grp A) vs LCBDE during LC (Grp B).

Randomised clinical trial.

Sample size calculation: yes.

Median length of follow-up: 1.88 (IQR, 1.38 to 3.15) yrs.


ParticipantsSingle centre.

Southmead Hospital, Bristol, UK

Higher-risk pts: defined as being > 70 yrs age, > 60 with comorbidity, or > 50 with a BMI greater than 40.

Pts with proven CBD stones on imaging or those with strong evidence of CBD stones (15 pts).

Strong evidence of those with CBD stones was defined as those with a dilated CBD on transabdominal USS (5 mm in a 50-yr old and 5+1 mm per decade) in addition to abnormal lLFTs.

2000 to 2006

Exclusion criteria:

Pts with previous sphincterotomy, previous Bilroth II gastrectomy, pts unfit for general anaesthesia.


InterventionsTotal of 91 pts.

Group A - 47 pts and Group B - 44 pts.


OutcomesMorbidity, bile duct clearance, conversion to open surgery, median postoperative stay.


NotesIf stones were confirmed on cholangiogram, sphincterotomy was performed and stones retrieved using balloon, basket, mechanical lithotripsy.

During post-ERCP LC, lap USS or cholangiography was performed. If stones were present, proceeded to LCBDE.

LCBDE group: Transcystic/transcholedochal approach was decided by intra-operative USS or cholangiogram.

Choledochoscope was used.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation was by an independent computer-generated random number system.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Rhodes 1998

MethodsRandomised clinical trial comparing LC and lap stone extraction versus LC and postoperative ERCP/ES and endoscopic stone extraction.

No protocol violations.

Pre-study power analysis apparently conducted, but details not listed.


ParticipantsNorwich. UK

Study commenced August 1995 and completed August 1997.

80 pts found to have stones and randomised.

Inclusion criteria:
LC for treatment of symptomatic gallstones with CBDS demonstrated on cholangiogram.

Exclusion criteria:
Pre-operative ERCP/ES.
No informed consent to proceed to randomisation.

Exclusions listed:
8 pre-operative ERCP/ES, 1 emergency OC and ECD 347 had no stones on IOC.

Essential investigations:
Pre-operative USS, IOC.


InterventionsLaparoscopic group:
Trans-cystic stone extraction if CBD < 9 mm diameter.
If failed or CBD ≥ 9 mm, stone extraction performed via choledochotomy, followed by stent or T-tube insertion.
Postoperative ERCP required for stent removal.
Post-operative ERCP or open conversion and duct exploration if laparoscopic extraction failed.

Endoscopic group:
ERCP and ES pre-operatively.
Repeated procedures until ducts clear.
Followed by laparoscopic cholecystectomy.


OutcomesSuccessful laparoscopic clearance, converted to open surgery, median (range) duration of all procedures, median (range) hospital stay.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskUnclear.

Allocation concealment (selection bias)Unclear riskUnclear.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Rogers 2010

MethodsLC+LCBDE vs ERCP/S+LC.

Randomised trial.

Follow-up: 10 protocol violators were excluded. Duration: 24 months.

Pre-study power analysis conducted, but not detailed.


ParticipantsUniversity of California, San Francisco.

1997 to 2003.

Inclusion criteria:

Age > 18 yrs, ability to consent, classic biliary pain, USS-cholecystolithiasis, platelet count/prothrombin time - normal, ASA grade 1 or 2, 'Likely' choledocholithiasis suggested by one of the following: CBD ≥ 6 mm by USS or CT scan, intrahepatic duct dilation as determined by USS or CT scan, serum bilirubin ≥ 2 mg/dl, ALP and/or lipase levels ≥ 1.5 times upper limit of normal within 48 hrs of intended procedure.

Exclusion criteria:

History of bleeding disorders, uraemia, USS/CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess or periampullary neoplasm, clinical or sonographic evidence of suppurative or necrotising cholecystitis, gallbladder empyema or perforation, IDDM, multiple prior laparotomies/morbid obesity/portal vein thrombosis, pregnancy.


Interventions122 pts.

LC+LCBDE: 61 pts = 57 pts

ERCP/S+LC: 61 pts = 55 pts

10 exclusions.


OutcomesCBD stones cleared, complications, procedure time.


NotesSphincterotomy was performed after confirming the presence of stones.

Transcystic exploration was performed for LCBDE.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised according to serially numbered, sealed, opaque envelopes.

Allocation concealment (selection bias)Low riskSealed, opaque envelopes.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Sgourakis 2002

MethodsRandomised clinical trial comparing laparoscopic surgery vs pre-operative ERCP and surgery.

Single centre.

Study commenced April 1997, completed August 2000.

Follow-up: drop-outs not reported.

Median postoperative 22.36 months (7 to 36).

Sample size calculations: no.


ParticipantsAthens, Greece.

78 pts randomised (36 Group A, 42 Group B) with high risk for CDS on USS and/or biochemical criteria.

ASA I or II pts.
8 pts excluded because of 'poor performance' status. Further 6 refused consent.


InterventionsLaparoscopic group - transcystic and choledochotomy approaches described in detail.
In ERCP group - surgery performed usually within 2 days.


OutcomesPrimary clearance success, morbidity, mortality, median hospital stay.


Notes8/36 of surgical arm (Group A) and 10/42 endoscopy arm (Group B) had no CBDS found at the time of the procedure.

No explanation given for choice of transcystic or direct CBD approaches in Group A.

1 pt in each group with CBDS in situ at end of trial.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskMethods of randomisation were ambiguous. The guidelines of a randomised trial with the probability of samples method and stratified sampling were applied. A preliminary retrospective study was conducted. Authors also mentioned: "Patients were assigned in two groups (LCBDE vs ERCP). All patients had an informed consent for their randomisation. We had to take into account and the preference of the surgeon responsible for their treatment." The author is not contactable at the provided email address.

Allocation concealment (selection bias)Unclear riskUnclear.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskUnclear.

Incomplete outcome dataLow riskUnclear.

For-profit biasLow riskUnclear.

Other biasLow riskUnclear.

Stain 1991

MethodsRandomised clinical trial of pts found to have CBDS on ERCP and fit to undergo surgery, randomised to either ERCP/ES + surgery or surgery "alone" .

Single centre.

All pts suspected of having CBDS (bilirubin > 2 mg/dl, raised amylase, USS evidence of CBDS) underwent ERCP.

Follow-up: exclusions not listed.
Drop-outs not listed.

Sample size calculations: no.

No power analysis stated.


ParticipantsLos Angeles. USA
52 pts completed the study.

Commencement and completion dates not stated.

Inclusion criteria:
Intact gallbladder, gallstones on USS, CBDS proven on ERC.

Exclusion criteria:
None stated.

Essential investigations: USS, serum biochemistry, ERC, IOC, T-tube cholangiogram in all having CBDE.


InterventionsGroup 1:
ERCP followed by ES and stone extraction by basket or spontaneous passage. Subsequent OC +/- CBDE in all cases. Surgery scheduled electively.
CBDE performed on basis of ERCP findings and IOC.

Group 2:
ERCP followed by OC scheduled electively. CBDE performed as necessary.


OutcomesMortality, morbidity, stone clearance rate, retained stones after surgery, operation time, hospital stay.


NotesPts in both groups had ERC, therefore surgery arm had complications of ERC.
Low ERCP/ES stone clearance rate (65%).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Stiegmann 1992

MethodsRandomised clinical trial.
Open cholecystectomy, IOC +/- bile duct exploration vs pre-operative ERCP/ES followed by OC.

Single centre.

Commenced June 1986, completed March 1990.

Exclusions not listed.

No protocol violations listed.

Sample size calculations: no.


ParticipantsDenver. USA.

34 pts randomised.

Inclusion criteria:
Pts for elective cholecystectomy, with suspected CBD stones.
Suspicion of CBDS based on having at least one of: serum bilirubin > 2 mg/dl (twice upper normal), serum ALP > 235 U/l (twice upper normal), serum amylase > 240 U/l (twice upper normal), ultrasound measured CD diameter > 8 mm, or USS visualisation of CBDS.

Exclusion criteria:
Asc cholangitis, op for acute cholecystitis, liver disease, bleeding disorders, previous gastric surgery precluding ERCP, previous biliary tract surgery.

Exclusions listed:
1 pt with cholangiocarcinoma found at ERCP and one with cirrhosis found at surgery excluded from further analysis.


InterventionsEndoscopic/Operative group:
ERCP/ES followed by OC plus IOC (usually the following day).

Operative only group:
OC + IOC +/- CBDE

Essential investigations:
Serum bilirubin, ALP, amylase, USS.
IOC in all pts.
Choledochoscopy in some of the surgical group.
ERCP/ES in the endoscopic group.
T-tube cholangiography in the surgical group at 10 days postoperatively.
Costing retrieved from hospital finance office.


OutcomesMortality, morbidity, stone clearance rates, hospital stay, procedure time, cost.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomised.

Allocation concealment (selection bias)Unclear riskNot clear.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Suc 1998

MethodsRandomised clinical trial.
Open cholecystectomy +/- ECD versus ERCP/ES. Cholecystectomy not necessarily performed in ERCP group.

Multicentre.

Exclusions - none listed.
Protocol violations - 9, all withdrawn.
Other withdrawals - 9, due to incorrect diagnosis (malignant biliary obstruction).

Sample size calculations: yes.
Power analysis based on primary outcome variable of additional procedures required, with 95 pts per group required with a power of 90% at the 0.05 level.


ParticipantsFrance.

Commenced September 1989 and completed September 1994.

220 consecutive adult pts randomised.

Inclusion criteria:
Adult (> 18 yrs).
One of: jaundice, mild AP, mild cholangitis, biliary colic + raised ALP, CDS or dilated CD on USS.

Exclusion criteria:
Cholecystitis (thick gallbladder wall on USS).
No stones on USS and CBD < 1 cm.
Pts unable to have ERCP (previous total or B2 gastrectomy, or choledochoenterostomy).


InterventionsAll cholecystectomies by surgeons, all ERCPs by gastroenterologists.

Surgical group:
OC (if not performed previously - 3 pts).
CBDE +/- choledochoscopy.
Duct closure either primary, +/- T-tube, or choledochoenterostomy.

Endoscopic group:
ERCP and cholangiogram.
Basket extraction of stones
OC subsequently only if cholecystitis or cholangitis developed.


OutcomesRetained stones, additional procedures, mortality, morbidity, total duration of hospital stay.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number tables.

Allocation concealment (selection bias)Low riskTelephone call to co-ordinating centre.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataLow riskNo missing data.

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

Targarona 1996

MethodsRandomised clinical trial of high-risk surgical pts suspected of having CBDS to either OC +/- CBDE alone or ERCP/ES and stone extraction alone.

Single centre.
9 excluded pre-randomisation due to no consent (5), acute cholecystitis (1), severe cholangitis requiring urgent surgery (2), severe pancreatitis requiring urgent ERCP/ES (1).

Sample size calculations: yes.
Power analysis based on reduced mortality of 14% with endoscopic treatment, requiring 48 pts per group (a = 0.05, b = 0.1).
If BDS diagnosed at time of ERCP, randomisation occurred during this procedure prior to ES.


ParticipantsBarcelona, Spain.

Commenced September 1991 and completed September 1994.

109 pts eligible: 9 exclusions pre-randomisation, 100 pts randomised, 2 early withdrawals post-randomisation.
98 pts with analysable data.

Inclusion criteria:
Pts with any combination of: biliary colic and jaundice, pancreatitis, and cholangitis, suspected of having BDS based on having:

cholestasis on LFTs, dilated BD > 8 mm on USS, CBDS on USS or ERCP, + deemed 'high surgical risk' on the basis of at least 1 of: age > 70 yrs, Goldman cardiac risk index > 13, COPD with PPO-MSV < 10 l/min, Child-Pugh class B or C, severely impaired mobility (neurological or locomotor), BMI > 30, informed consent, intact gallbladder.

Exclusion criteria: previous ES, previous cholecystectomy.


InterventionsIf the allocated therapy could not be performed within 30 days post-randomisation, it was classed as a primary failure of that therapy.

Group 1: (surgery)
OC performed post-randomisation.
IOC performed in all and CBDE as required.

Group 2: (endoscopy)
ERCP performed post-randomisation.
ES performed regardless of presence of stones on cholangiogram.


OutcomesPrimary duct clearance rate, total morbidity, mortality, total hospital stay, recurrent biliary symptoms, readmissions due to recurrent symptoms.


NotesES performed in Group 2 even if no stones present - this does not reflect normal practice and may increase risk in this group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table.

Allocation concealment (selection bias)Low riskClosed envelopes with group distribution.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible.

Selective reporting (reporting bias)Low riskNone.

Incomplete outcome dataUnclear riskIncomplete outcome data (hospital stay).

For-profit biasLow riskAppears free of for-profit support.

Other biasLow riskNone.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Airan 1992Retrospective and prospective case series of LC +/- laparoscopic exploration of common bile duct.

Ammori 2000Prospective study comparing pre-operative ERCP/ES + LC compared to LC + laparoscopic exploration of common bile duct . Not randomised.

Andreasen 1998Retrospective series of peri-operative ERCP + LC.

Berci 1994Case series of laparoscopic exploration of common duct.

Bergamaschi 1999Case series of pre-operative ERCP/ES + LC.

Boeckl 1988Study comparing pre-operative ERCP/ES + OC versus OC +/- (open) exploration of common duct (with a view to stone extraction).

Boerma 2002A randomised trial comparing wait-and-see or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones.

Bonatsos 1996Case series of pre-operative ERCP/ES + LC.

Budzynski 1997Case series of pre-operative ERCP/ES + LC.

Cemachovic 2000Retrospective case series of LC + intra-operative ERCP/ES.

Chan 1996Prospective case series of pre-operative ERCP/ES + LC.

Chang 2000Randomised clinical trial comparing pre-operative versus postoperative ERCP and LC in mild to moderate gallstone pancreatitis. 60 randomised pts with gallstone pancreatitis and suspicion of common duct calculi on US and biochemistry. ERCP required in only 24% of postoperative group based on IOC. Treatment failure 10% in both groups, but higher costs and longer hospital stay in pre-operative group. Excluded as the pre - and postoperative ERP were the comparison groups.

Cisek 1994Case series of pre-operative ERCP/ES + LC.

Conigliaro 1995Non-randomised study for CBD stone treatment into 4 groups:
(1) ES and LC, (2) Pre-op ERCP and LC, (3) Open surgery, (4) Laparoscopic bile duct exploration.

Coppola 1996Case series of pre-operative ERCP/ES + LC.

Daradkeh 2000Prospective case series of pre-operative ERCP/ES + LC.

Davis 1997Case series of peri-operative ERCP/ES + LC.

Decker 2003Cohort of 100 laparoscopic choledochotomies with primary closure of the bile duct.

Dias 2002Survey of surgeons in NSW Australia regarding management of CBD stones.

Drouard 1995Case series of laparoscopic exploration of common duct (with a view to stone extraction).

Drouard 1997Case series of laparoscopic exploration of common duct (with a view to stone extraction).

Ebner 2004Cohort of 200 pts undergoing laparoscopic management of bile duct stones (115 transcystic, 85 choledochotomy). 91% clearance. 7% 'complication rate'. 0.5% mortality.

El Geidie 2011Compares the timing of ERCP in relation to LC.

Fanning 1997Retrospective study comparing pre-operative ERCP/ES + LC to LC +/- laparoscopic exploration of common duct (with a view to stone extraction).

Frazee 1993Case series of pre-operative ERCP/ES + LC.

Galloway 1994Prospective non-randomised study of combined laparoscopic and endoscopic treatment of gallstones and bile duct stones:

Giurgiu 1999Prospective case series of laparoscopic exploration of common duct (with a view to stone extraction).

Gonzalez 1989Prospective study comparing pre-operative ERCP/ES + open cholecystectomy versus open cholecystectomy + (open) exploration of common duct (with a view to stone extraction).

Hamy 2003Case series of pre-operative ERCP prior to laparoscopic cholecystectomy.

Heili 1999Retrospective study comparing pre-operative ERCP/ES + LC to LC +/- laparoscopic exploration of common duct (with a view to stone extraction).

Heinerman 1989Non-randomised comparison between surgical and endoscopic common bile duct stone extraction.

Hoyuela 1999Case series of pre-operative ERCP/ES + LC.

Hui 2002A randomised study of ERCP vs no ERCP in acute acalculous cholangitis.

Huynh 1996Case series of pre-operative ERCP/ES + LC.

Kapoor 1994Non-randomised comparison between open cholecystectomy +/- open exploration of common duct (with a view to stone extraction) and ERCP/ES +/- open cholecystectomy.

Khuroo 1989Randomisation to biliary drainage (ie, not stone removal) and surgery.

Kullman 1996Prospective case series of pre-operative and postoperative ERCP/ES + LC. Not a RCT.

Lai 1992Randomisation to biliary drainage (ie, not stone removal) and surgery.

Lella 2006Compares the timing of ERCP in relation to LC.

Lezoche 1996Prospective case series of LC +/- laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Lezoche 2000Case series of laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Liberman 1996Retrospective study comparing LC +/- postoperative ERCP/ES to LC +/- laparoscopic exploration of common duct (with a view to stone extraction).

Liu 1996Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Magnanini 1994Case series of pre-operative ERCP/ES + LC.

Martin 1998Case series of 300 LC + laparoscopic exploration of common duct (with a view to stone extraction).

Martin 2002Cohort series of 56 pts undergoing attempted laparoscopic transcystic bile duct stenting in the management of common bile duct stones.

Masci 1999Case series of pre-operative ERCP/ES + LC.

Materia 1996Case series of pre-operative ERCP/ES + LC.

Meyer 1999Study comparing peri-operative ERCP/ES + LC to LC +/- laparoscopic exploration of common duct (with a view to stone extraction) to open cholecystectomy +/- open exploration of common duct (with a view to stone extraction).

Meyer 2002Cohort of common bile duct stone management in a single operation combining laparoscopic cholecystectomy and pre-operative endoscopic sphincterotomy.

Michel 2000Retrospective case series of laparoscopic exploration of common duct (with a view to stone extraction).

Mijal 1997Study comparing pre-operative ERCP/ES + LC to open cholecystectomy + open exploration of common duct (with a view to stone extraction). Not a RCT.

Millat 1995Prospective case series of laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Millat 1996Prospective case series of laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Millat 1997Case series of laparoscopic exploration of common duct (with a view to stone extraction).

Miller 1988Retrospective study comparing ERCP/ES to open cholecystectomy +/- open exploration of common duct (with a view to stone extraction).

Mo 2002Study of pre-operative endoscopic sphincterotomy in the treatment of pts with cholecystocholedocholithiasis.

Moreaux 1995Prospective case series of open cholecystectomy +/- open exploration of common duct (with a view to stone extraction). Not a RCT.

Morino 2006Compares the timing of ERCP in relation to LC.

Neoptolemos 89Retrospective and prospective study comparing open cholecystectomy +/- open exploration of common duct (with a view to stone extraction) to ERCP/ES +/- open cholecystectomy.

Neuhaus 1992Prospective case series of pre-operative ERCP + LC. Not a RCT.

Niu 1995Case series of laparoscopic exploration of common duct (with a view to stone extraction).

Paganini 1998Prospective case series of LC +/- laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Palacios-Macedo 1995Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Pedersen 1998Retrospective case series of pre-operative ERCP/ES.

Pereira-Lima 2001Cohort series of ERCP CDS clearence in the era of laparoscopic cholecystectomy: prospective analysis of 386 pts.

Perniceni 2001Case series of laparoscopic exploration of common duct (with a view to stone extraction).

Phillips 1995Retrospective case series of LC +/- laparoscopic exploration of common duct (with a view to stone extraction).

Quershi 1993Case series of pre- and postoperative ERCP/ES.

Rabago 2006Compares the timing of ERCP in relation to LC.

Rhodes 1995Retrospective case series of laparoscopic exploration of common duct (with a view to stone extraction).

Rieger 1994Case series of pre-operative ERCP/ES + LC.

Rieger 1995Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Rijna 2000Case series of pre-operative ERCP/ES + LC.

Robertson 1996Case series of ERCP/ES followed by LC.

Robinson 1995Case series of LC +/- laparoscopic exploration of common duct (with a view to stone extraction).

Roush 1995Retrospective case series of laparoscopic exploration of common duct (with a view to stone extraction).

Santucci 1996Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Sarli 1999Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Schwab 1992Prospective study comparing OC+/- ECD to ERCP/ES. Not a RCT.

Seo 2000Prospective case series of ERCP/ES. Not an RCT.

Stoker 1995Prospective case series of LC +/- laparoscopic exploration of common duct (with a view to stone extraction). Not a RCT.

Sugiyama 1999Prospective case series of laparoscopic exploration of common duct (with a view to stone extraction).

Sungler 1993Prospective case series of pre-operative ERCP/ES + LC.

Sungler 1997Prospective case series of pre-operative ERCP/ES + LC.

Tham 1998Case series of pre-operative ERCP/ES + LC.

Trias 1997Prospective case series of pre-operative ERCP/ES + LC.

Trondsen 1995Retrospective case series of pre-operative ERCP/ES + open cholecystectomy.

Turcu 1997Prospective study comparing pre-operative ERCP/ES + open cholecystectomy to open cholecystectomy + open exploration of common duct (with a view to stone extraction). Not a RCT.

Waage 2003Cohort series of 175 attempted laparoscopic bile duct exploration (110 transcystic, 52 lap choledochotomy and 13 open conversion). Morbidity 6.9%. Mortality 0%. Median follow-up 36 months with 1 recurrence of CBS and no strictures.

Welbourn 1995Retrospective case series of pre-operative ERCP/ES + LC.

Wenner 2005Cohort series of 23 pts undergoing laparoscopic bile duct exploration using a Multichannel Instrument Guide. 95% stone clearance rate.

Widdison 1994Prospective case series of pre-operative ERCP/ES + LC. Not a RCT.

Wilson 1993Case series of peri-operative ERCP/ES + LC.

Worthley 1989Prospective study comparing pre-operative ERCP/ES + open cholecystectomy to open cholecystectomy + open exploration of common duct (with a view to stone extraction). Not a RCT.

Zargar 2002Case series of ERCP in the treatment of common bile duct stones.

 
Comparison 1. Open surgery versus ERCP

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mortality8729Odds Ratio (M-H, Fixed, 95% CI)0.51 [0.18, 1.44]

    1.1 Randomisation once bile duct stones proven
4275Odds Ratio (M-H, Fixed, 95% CI)0.39 [0.06, 2.72]

    1.2 Randomisation on suspicion of bile duct stones
3356Odds Ratio (M-H, Fixed, 95% CI)0.48 [0.09, 2.65]

    1.3 High-risk participants only
198Odds Ratio (M-H, Fixed, 95% CI)0.68 [0.11, 4.27]

 2 Mortality (Sensitivity analysis)8Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Good-outcome analysis
8737Odds Ratio (M-H, Fixed, 95% CI)0.50 [0.18, 1.42]

    2.2 Poor-outcome analysis
8737Odds Ratio (M-H, Fixed, 95% CI)1.00 [0.43, 2.32]

    2.3 Best-case for open surgery
8737Odds Ratio (M-H, Fixed, 95% CI)0.46 [0.17, 1.25]

    2.4 Worst-case for open surgery
8737Odds Ratio (M-H, Fixed, 95% CI)1.10 [0.47, 2.55]

 3 Total morbidity8729Odds Ratio (M-H, Fixed, 95% CI)1.12 [0.77, 1.62]

    3.1 Randomisation once bile duct stones proven
4275Odds Ratio (M-H, Fixed, 95% CI)1.02 [0.59, 1.77]

    3.2 Randomisation on suspicion of bile duct stones
3356Odds Ratio (M-H, Fixed, 95% CI)1.11 [0.63, 1.96]

    3.3 High-risk participants only
198Odds Ratio (M-H, Fixed, 95% CI)1.56 [0.57, 4.30]

 4 Morbidity (Sensitivity analysis)8Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Good-outcome analysis
8737Odds Ratio (M-H, Fixed, 95% CI)1.09 [0.76, 1.58]

    4.2 Poor-outcome analysis
8737Odds Ratio (M-H, Fixed, 95% CI)1.19 [0.83, 1.71]

    4.3 Best-case for open surgery
8737Odds Ratio (M-H, Fixed, 95% CI)1.07 [0.74, 1.54]

    4.4 Worst-case for open surgery
8737Odds Ratio (M-H, Fixed, 95% CI)1.22 [0.84, 1.75]

 5 Retained stones7609Odds Ratio (M-H, Fixed, 95% CI)0.36 [0.21, 0.62]

    5.1 Randomisation once bile duct stones proven
4275Odds Ratio (M-H, Fixed, 95% CI)0.35 [0.17, 0.72]

    5.2 Randomisation on suspicion of bile duct stones
2236Odds Ratio (M-H, Fixed, 95% CI)0.30 [0.12, 0.74]

    5.3 High-risk participants only
198Odds Ratio (M-H, Fixed, 95% CI)3.19 [0.13, 80.23]

 6 Retained stones (Sensitivity analysis)7Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 Good-outcome analysis
7617Odds Ratio (M-H, Fixed, 95% CI)0.35 [0.20, 0.60]

    6.2 Poor-outcome analysis
7617Odds Ratio (M-H, Fixed, 95% CI)0.46 [0.28, 0.76]

    6.3 Best-case for open surgery
7617Odds Ratio (M-H, Fixed, 95% CI)0.34 [0.20, 0.58]

    6.4 Worst-case for open surgery
7609Odds Ratio (M-H, Fixed, 95% CI)0.36 [0.21, 0.62]

 7 Failure of procedure7609Odds Ratio (M-H, Fixed, 95% CI)0.31 [0.19, 0.51]

    7.1 Randomisation once CBD stones confirmed
4275Odds Ratio (M-H, Fixed, 95% CI)0.29 [0.14, 0.60]

    7.2 Randomisation on suspicion of bile duct stones
2236Odds Ratio (M-H, Fixed, 95% CI)0.29 [0.13, 0.66]

    7.3 High-risk participants only
198Odds Ratio (M-H, Fixed, 95% CI)0.49 [0.12, 2.08]

 8 Hospital stayOther dataNo numeric data

    8.1 Randomisation once CBD stones were proven
Other dataNo numeric data

    8.2 Randomisation on suspicion of CBD stones
Other dataNo numeric data

    8.3 High-risk participants only
Other dataNo numeric data

 9 Cost134Mean Difference (IV, Fixed, 95% CI)1102.0 [299.54, 1904.46]

 
Analysis 1.8 Comparison 1 Open surgery versus ERCP, Outcome 8 Hospital stay.
Hospital stay

StudyDuration of hospital stay from

the day of intervention (surgery group)
Duration of hospital stay from

the day of intervention (endoscopy group)

Randomisation once CBD stones were proven

Hammarstrom 1995Not reported13

Kapoor 199611.3 (range 6 to 24)10.6 (range 6 to 18)

Neoptolemos 198711 (range 6 to 27)9 (range 4 to 57)

Stain 19917 ( range 4 to 22)5 (range 2 to 12)

Randomisation on suspicion of CBD stones

Stiegmann 19929.2 +/- 0.6 days (mean +/- SD)11.0 +/- 1.5 days (mean +/- SD)

Suc 199816 (range 6 to 60)12 (range 2 to 68)

High-risk participants only

Targarona 1996Not reported.Not reported.

 
Comparison 2. LC + LCBDE versus pre-operative ERCP + LC

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mortality5580Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.12, 4.33]

    1.1 Low-risk group
4489Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.12, 4.33]

    1.2 High-risk group
191Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Mortality (Sensitivity analysis)5Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Good-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)0.71 [0.12, 4.27]

    2.2 Poor-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)1.01 [0.55, 1.85]

    2.3 Best-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)0.10 [0.03, 0.38]

    2.4 Worst-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)7.46 [2.39, 23.27]

 3 Total morbidity5580Odds Ratio (M-H, Fixed, 95% CI)1.28 [0.80, 2.05]

    3.1 Low-risk group
4489Odds Ratio (M-H, Fixed, 95% CI)1.11 [0.66, 1.87]

    3.2 High-risk group
191Odds Ratio (M-H, Fixed, 95% CI)2.47 [0.77, 7.92]

 4 Morbidity (Sensitivity analysis)5Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Good-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)1.27 [0.79, 2.03]

    4.2 Poor-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)1.21 [0.81, 1.80]

    4.3 Best-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)0.76 [0.49, 1.16]

    4.4 Worst-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)2.02 [1.30, 3.14]

 5 Retained stones5580Odds Ratio (M-H, Fixed, 95% CI)0.79 [0.45, 1.39]

    5.1 Low-risk group
4489Odds Ratio (M-H, Fixed, 95% CI)1.00 [0.55, 1.82]

    5.2 High-risk group
191Odds Ratio (M-H, Fixed, 95% CI)0.07 [0.00, 1.31]

 6 Retained stones (Sensitivity analysis)5Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 Good-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)0.78 [0.45, 1.37]

    6.2 Poor-outcome analysis
5621Odds Ratio (M-H, Fixed, 95% CI)0.88 [0.57, 1.37]

    6.3 Best-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)0.44 [0.26, 0.73]

    6.4 Worst-case for LCBDE
5621Odds Ratio (M-H, Fixed, 95% CI)1.57 [0.96, 2.55]

 7 Failure of procedure5580Odds Ratio (M-H, Random, 95% CI)0.51 [0.16, 1.59]

    7.1 Low-risk group
4489Odds Ratio (M-H, Random, 95% CI)0.81 [0.46, 1.41]

    7.2 High-risk group
191Odds Ratio (M-H, Random, 95% CI)0.02 [0.00, 0.37]

 8 Conversion to open surgery5580Odds Ratio (M-H, Fixed, 95% CI)1.46 [0.76, 2.81]

    8.1 Low-risk group
4489Odds Ratio (M-H, Fixed, 95% CI)1.36 [0.67, 2.75]

    8.2 High-risk group
191Odds Ratio (M-H, Fixed, 95% CI)2.25 [0.39, 12.95]

 9 Duration of hospital stayOther dataNo numeric data

 
Analysis 2.9 Comparison 2 LC + LCBDE versus pre-operative ERCP + LC, Outcome 9 Duration of hospital stay.
Duration of hospital stay

StudyPre-op ERCP + LCLC + LCBDEP - value

Bansal 20104 (range 2 to 11) days4.2 (range 3 to 9) days

Cuschieri 19999 (IQR, 6 to 14) days6 (IQR, 4 to 12) days<0.05

Noble 20093 (IQR, 2 to 7) days5 (IQR, 2 to 7) days0.825

Rogers 201098hrs55hrs<0.001

Sgourakis 20029 days7.4 days

 
Comparison 3. LC + LCBDE versus LC + intra-operative ERCP

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Morbidity1Odds Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Retained stones1234Odds Ratio (M-H, Fixed, 95% CI)0.64 [0.20, 2.06]

 3 Failure of procedure1234Odds Ratio (M-H, Fixed, 95% CI)0.88 [0.19, 4.01]

 4 Conversion to open surgery1234Odds Ratio (M-H, Fixed, 95% CI)1.26 [0.51, 3.11]

 5 Duration of procedure1234Mean Difference (IV, Fixed, 95% CI)-6.49 [-21.47, 8.49]

 6 Duration of hospital stayOther dataNo numeric data

 7 CostOther dataNo numeric data

 
Analysis 3.6 Comparison 3 LC + LCBDE versus LC + intra-operative ERCP, Outcome 6 Duration of hospital stay.
Duration of hospital stay

StudyIntra-op ERCP + LCLC + LCBDE

Hong 20064.25 +/- 3.464.66 +/- 3.07

 
Analysis 3.7 Comparison 3 LC + LCBDE versus LC + intra-operative ERCP, Outcome 7 Cost.
Cost

StudyIntra-op ERCP + LCLC + LCBDE

Hong 200617279.96 + / - 4097.4313559.20 +/- 3452.10

 
Comparison 4. LC + LCBDE versus LC + postoperative ERCP

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Total morbidity2166Odds Ratio (M-H, Fixed, 95% CI)1.16 [0.50, 2.72]

    1.1 LCBDE versus post-operative ERCP
180Odds Ratio (M-H, Fixed, 95% CI)1.0 [0.29, 3.41]

    1.2 LCBDE versus post-operative ERCP (intra-operative randomisation)
186Odds Ratio (M-H, Fixed, 95% CI)1.34 [0.41, 4.37]

 2 Retained stones after primary intervention2166Odds Ratio (M-H, Fixed, 95% CI)0.28 [0.11, 0.72]

    2.1 LCBDE versus post-operative ERCP
180Odds Ratio (M-H, Fixed, 95% CI)0.53 [0.17, 1.63]

    2.2 LCBDE versus post-operative ERCP (intra-operative randomisation)
186Odds Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.63]

 3 Failure of procedure2166Odds Ratio (M-H, Fixed, 95% CI)0.47 [0.21, 1.06]

    3.1 LCBDE versus post-operative ERCP
180Odds Ratio (M-H, Fixed, 95% CI)1.0 [0.36, 2.75]

    3.2 LCBDE versus post-operative ERCP (intra-operative randomisation)
186Odds Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.63]

 4 Conversion to open surgery2166Odds Ratio (M-H, Fixed, 95% CI)1.77 [0.23, 13.81]

    4.1 LCBDE versus post-operative ERCP
180Odds Ratio (M-H, Fixed, 95% CI)3.08 [0.12, 77.80]

    4.2 LCBDE versus post-operative ERCP (intra-operative randomisation)
186Odds Ratio (M-H, Fixed, 95% CI)1.1 [0.07, 18.17]

 5 Duration of procedureOther dataNo numeric data

 6 Duration of hospital stayOther dataNo numeric data

 
Analysis 4.5 Comparison 4 LC + LCBDE versus LC + postoperative ERCP, Outcome 5 Duration of procedure.
Duration of procedure

StudyPost-op ERCP + LCLC + LCBDEP

Nathanson 2005147.9 min (both procedures together)158.8 min (both procedures together)0.49

Rhodes 1998105 (60-255) min (both procedures together)90 (25-310) min (both procedures together)0.1

 
Analysis 4.6 Comparison 4 LC + LCBDE versus LC + postoperative ERCP, Outcome 6 Duration of hospital stay.
Duration of hospital stay

StudyLC + post-op ERCPLC + LCBDEP

Nathanson 2005Mean: 7.7 daysMean: 6.4 days0.57

Rhodes 19983.5 days (1-11 days)1 day (1-26 days)0.0001

 
Comparison 5. Single-stage versus two-stage management

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Mortality7746Odds Ratio (M-H, Fixed, 95% CI)0.72 [0.12, 4.33]

 2 Mortality (Sensitivity analysis)7Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Good-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)0.71 [0.12, 4.27]

    2.2 Poor-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)1.01 [0.55, 1.85]

    2.3 Best-case for single stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)0.10 [0.03, 0.38]

    2.4 Worst-case for single-stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)7.46 [2.39, 23.27]

 3 Morbidity7746Odds Ratio (M-H, Fixed, 95% CI)1.25 [0.83, 1.89]

 4 Morbidity (Sensitivity analysis)7Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 Good-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)1.24 [0.82, 1.87]

    4.2 Poor-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)1.20 [0.84, 1.72]

    4.3 Best-case for single-stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)0.82 [0.56, 1.21]

    4.4 Worst-case for single-stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)1.80 [1.22, 2.66]

 5 Retained stones7746Odds Ratio (M-H, Random, 95% CI)0.58 [0.28, 1.22]

 6 Retained stones (Sensitivity analysis)7Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 Good-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)0.58 [0.37, 0.93]

    6.2 Poor-outcome analysis
7787Odds Ratio (M-H, Fixed, 95% CI)0.70 [0.47, 1.03]

    6.3 Best-case for single-stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)0.39 [0.25, 0.62]

    6.4 Worst-case for single-stage procedure
7787Odds Ratio (M-H, Fixed, 95% CI)1.03 [0.69, 1.56]

 7 Failure to complete the procedure7746Odds Ratio (M-H, Random, 95% CI)0.49 [0.20, 1.18]

 8 Conversion to open surgery7746Odds Ratio (M-H, Fixed, 95% CI)1.49 [0.80, 2.77]

 
Summary of findings for the main comparison. Open surgery compared to ERCP for bile duct stones

Open surgery compared to ERCP for bile duct stones

Patient or population: with common bile duct stones
Settings: secondary or tertiary hospital
Intervention: open surgery
Comparison: ERCP + LC

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ERCP + LCOpen surgery

MortalityStudy population0.51
(0.18 to 1.44)
733
(8 studies)
⊕⊕⊕⊝
moderate1,2

3 per 1001 per 100
(0 to 4)

Moderate

2 per 1001 per 100
(0 to 3)

Total morbidityStudy populationOR 1.12
(0.77 to 1.62)
729
(8 studies)
⊕⊕⊕⊝
moderate1

19 per 10021 per 100
(15 to 27)

Moderate

17 per 10019 per 100
(14 to 25)

Failure of procedureStudy populationOR 0.32
(0.21 to 0.48)
943
(7 studies)
⊕⊕⊕⊝
moderate1,2

200 per 100074 per 1000
(50 to 107)

Moderate

188 per 100069 per 1000
(46 to 100)

Retained stones after primary interventionStudy populationOR 0.36
(0.23 to 0.57)
943
(7 studies)
⊕⊕⊕⊝
moderate3

144 per 100057 per 1000
(37 to 87)

Moderate

165 per 100066 per 1000
(43 to 101)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 High-risk surgical participants are included in one trial.
2 Bornman 1992 is not a published trial and therefore could not be included in all the outcome analysis.
3 Randomisation of the studies was performed on confirmation of ductal stones and on suspicion of ductal stones in these studies.
 
Summary of findings 2. LC + LCBDE versus pre-operative ERCP + LC for common bile duct stones

LC + LCBDE versuspre-operative ERCP + LC for common bile duct stones

Patient or population: with common bile duct stones
Settings: secondary or tertiary hospital
Intervention: LC+ LCBDE

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlLC+ LCBDE

Mortality at 30 daysStudy populationOR 0.72
(0.12 to 4.33)
580
(5 studies)
⊕⊕⊕⊝
moderate1

10 per 10007 per 1000
(1 to 43)

Moderate

0 per 10000 per 1000
(0 to 0)

Total morbidityStudy populationOR 1.28
(0.8 to 2.05)
580
(5 studies)
⊕⊕⊕⊝
moderate1

125 per 1000155 per 1000
(103 to 227)

Moderate

125 per 1000155 per 1000
(103 to 227)

Failure of procedureStudy populationOR 0.51
(0.16 to 1.59)
580
(5 studies)
⊕⊕⊕⊕
moderate1
Random-effects model

166 per 100092 per 1000
(31 to 241)

Moderate

169 per 100094 per 1000
(32 to 244)

Retained stones after primary interventionStudy populationOR 0.79
(0.45 to 1.39)
580
(5 studies)
⊕⊕⊕⊕
moderate1

105 per 100085 per 1000
(50 to 140)

Moderate

125 per 1000101 per 1000
(60 to 166)

Conversion to open surgeryStudy populationOR 1.46
(0.76 to 2.81)
580
(5 studies)
⊕⊕⊕⊕
moderate1

58 per 100082 per 1000
(44 to 147)

Moderate

59 per 100084 per 1000
(45 to 150)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Included low-risk and high-risk groups of surgical participants
 
Summary of findings 3. LC + LCBDE compared to LC + post-operative ERCP for common bile duct stones

LC + LCBDE compared withLC + post-operativeERCP for common bile duct stones

Patient or population: with common bile duct stones
Settings: secondary or tertiary hospital
Intervention: LC + LCBDE
Comparison: LC + postoperative ERCP

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

LC + post-operativeERCPLC + LCBDE

Total morbidityStudy populationOR 1.16
(0.5 to 2.72)
166
(2 studies)
⊕⊕⊕⊝
moderate1,2

141 per 1000160 per 1000
(76 to 309)

Moderate

142 per 1000161 per 1000
(76 to 310)

Failure of procedureStudy populationOR 0.47
(0.21 to 1.06)
166
(2 studies)
⊕⊕⊕⊝
moderate2

247 per 1000134 per 1000
(64 to 258)

Moderate

247 per 1000134 per 1000
(64 to 258)

Retained stones after primary interventionStudy populationOR 0.28
(0.11 to 0.72)
166
(2 studies)
⊕⊕⊕⊝
moderate2

247 per 100084 per 1000
(35 to 191)

Moderate

247 per 100084 per 1000
(35 to 191)

Conversion to open surgeryStudy populationOR 1.77
(0.23 to 13.81)
166
(2 studies)
⊕⊕⊕⊝
moderate2

12 per 100021 per 1000
(3 to 141)

Moderate

11 per 100019 per 1000
(3 to 133)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Rhodes 1998 is considered to be at unclear risk of bias at randomisation.
2 Nathanson 2005 randomised participants with ductal stones at laparoscopic cholecystectomy after failed transcystic clearance to laparoscopic choledochotomy or postoperative ERCP.
 
Table 1. Participant age

Study IDERCPSurgery

Bansal 2010Mean (range): 39.07 (23 to 64)Mean (range): 47.1 (34 to72)

Bornman 1992Mean (SD): 54 (14)Mean (SD): 55 (15)

Cuschieri 1999Range: 18 to 89Range: 19 to 88

Hammarstrom 1995Median (range): 75 (56 to 85)Median (range): 73.5 (56 to 85)

Hong 2006Not stated.15 to 82 years (mean, 48)

Kapoor 1996Mean (range): 42 (20 to 60)Mean (range): 46 (24 to 75)

Nathanson 2005Median (range): 59.6 (18 to 92)Median (range): 56.1 (17 to 91)

Neoptolemos 1987Median (range): 61 (20 to 83)Median (range): 59 (20 to 82)

Noble 200974.3 (70.0 to 78.9)75.9 (70 to 80.8)

Rhodes 1998Mean (range): 68 (28 to 84)Mean (range): 62 (24 to 83)

Rogers 2010Mean 44.6Mean 39.9

Sgourakis 2002Range: 46 to 89Range: 43 to 88

Stain 1991Mean (range): 48.4 (31 to 78)Mean (range): 42.4 (20 to 86)

Stiegmann 1992Mean (SD): 46.3 (21.7)Mean (SD): 38.1 (14.8)

Suc 1998Mean (SD): 66.8 (17.5)Mean (SD): 66.7 (18.1)

Targarona 1996Mean (SD): 79 (9)Mean (SD): 80 (7)

 
Table 2. Participant sex distribution

Study IDERCPSurgery

Bansal 2010M:F 5:10M:F 4:11

Bornman 1992M:F 17:45M:F 10:48

Cuschieri 1999M:F 42:108M:F 60:90

Hammarstrom 1995M:F 12:27 )M:F 16:25

Hong 2006Not statedM:F (ratio) 28:65

Kapoor 1996Not statedNot stated

Nathanson 2005M:F 17:28M:F 16:25

Neoptolemos 1987M:F 29:26M:F 24:35

Noble 2009M:F 22:25M:F 16:28

Rhodes 1998M:F 14:26M:F 12:28 )

Rogers 2010M:F 16:39M:F 17:40

Sgourakis 2002M:F 17:25M:F 15:21

Stain 1991M:F 6:20M:F 3:23

Stiegmann 1992Not statedNot stated

Suc 1998M:F 31:66M:F 33:72

Targarona 1996M:F 15:35M:F 15:33

 
Table 3. Follow-up duration

Study IDERCPSurgery

Bansal 2010not statednot stated

Bornman 1992not statednot stated

Cuschieri 1999not statednot stated

Hammarstrom 1995median: 92 monthsmedian: 82 months

Hong 2006not statednot stated

Kapoor 1996not statednot stated

Nathanson 2005not statednot stated

Neoptolemos 1987minimum of 6 monthsminimum of 6 months

Noble 2009at least 1 yearat least 1 year

Rhodes 1998not statednot stated

Rogers 2010not statednot stated

Sgourakis 2002median: 22.36 monthsmedian: 22.36 months

Stain 1991not statednot stated

Stiegmann 1992not statednot stated

Suc 1998not statednot stated

Targarona 1996mean (sd): 15 (11) monthsmean (sd): 18 (10) months