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Early versus delayed laparoscopic cholecystectomy for acute gallstone pancreatitis

  1. Kurinchi Selvan Gurusamy1,*,
  2. Myura Nagendran2,
  3. Brian R Davidson1

Editorial Group: Cochrane Upper GI and Pancreatic Diseases Group

Published Online: 2 SEP 2013

Assessed as up-to-date: 22 JAN 2013

DOI: 10.1002/14651858.CD010326.pub2


How to Cite

Gurusamy KS, Nagendran M, Davidson BR. Early versus delayed laparoscopic cholecystectomy for acute gallstone pancreatitis. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD010326. DOI: 10.1002/14651858.CD010326.pub2.

Author Information

  1. 1

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

  2. 2

    Department of Surgery, UCL Division of Surgery and Interventional Science, London, UK

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, NW3 2PF, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 2 SEP 2013

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

MethodsRandomised clinical trial


ParticipantsCountry: USA.

Number randomised: 51.

Post-randomisation drop-outs: 1 (1.9%).

Revised sample size: 49.

Average age: 37 years.

Women: 5 (10%).

Inclusion criteria

All adults between the age of 18 and 100 with mild gallstone pancreatitis.

A subject was classified as having gallstone pancreatitis if they had the following:

  • Upper abdominal pain, nausea, vomiting, and epigastric tenderness.
  • Absence of ethanol abuse.
  • Elevated amylase level to at least twice the upper limit of normal and elevated lipase level to at least 3 times the upper limit of normal
  • Imaging confirmation of gallstones.


The classification of mild pancreatitis was defined by the presence of the following:

  • 3 or fewer Ranson criteria on admission.
  • Clinical stability with admission to a non-monitored ward bed.
  • Absence of acute cholangitis.
  • Low suspicion for a retained common bile duct (CBD) stone.


Exclusion criteria

  • Severe pancreatitis (as defined by the presence of more than 3 Ranson criteria on admission).
  • Suspected concomitant acute cholangitis.
  • High suspicion for retained common bile duct stone.
  • Refusal to participate.
  • Severe pre-existing medical co-morbidities contraindicating cholecystectomy.
  • Pregnancy.
  • Prior gastric bypass surgery.
  • Admission to a monitored unit.


InterventionsParticipants were randomly assigned to 2 groups.
Group 1: early laparoscopic cholecystectomy (n = 25).
Further details: surgery within 48 hours of admission and potentially before normalisation of laboratory values and resolution of abdominal symptoms.
Group 2: delayed laparoscopic cholecystectomy (n = 25).
Further details: surgery after resolution of abdominal pain and normalisation of laboratory values.


OutcomesThe outcomes reported were mortality, serious adverse events, conversion to open cholecystectomy and hospital stay.


NotesOne participant in the delayed laparoscopic cholecystectomy group did not undergo surgery because the cause of pancreatitis was deemed to be hypertriglyceridaemia. This person developed myocardial infarction and the authors excluded him from the analysis. We included this person in all the outcomes except hospital stay.

Attempts were made to contact the authors in January 2013.

Source of funding: Not stated.

Conflicts of interest: Not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Random assignment was performed by drawing a sealed, unlabeled, unordered envelope from a container by an independent party immediately after informed consent was obtained".

Allocation concealment (selection bias)Low riskQuote: "Random assignment was performed by drawing a sealed, unlabeled, unordered envelope from a container by an independent party immediately after informed consent was obtained".

Blinding of participants and personnel (performance bias)
All outcomes
High riskComment: It is not possible to blind the participants and healthcare providers unless sham surgery was provided, which may be unethical.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: This information was not available.

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: Although one participant who developed myocardial infarction was not included in the analysis of the hospital stay, inclusion of this participant is likely to increase rather than decrease the difference.

Selective reporting (reporting bias)Low riskComment: All important outcomes expected to be measured in such a trial were reported.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

ISRCTN42476855Although reported in the trial registry, this trial suffered from lack of participants and hence was not reported (author replies).

 
Characteristics of ongoing studies [ordered by study ID]
Bouwense 2012

Trial name or titlePancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO)

MethodsRandomised controlled trial

ParticipantsPatients with acute biliary pancreatitis

InterventionsEarly laparoscopic cholecystectomy (within 72 hours after recovery of a first episode of mild biliary pancreatitis versus delayed laparoscopic cholecystectomy (25 to 30 days after recovery of pancreatitis)

OutcomesMortality and readmissions

Starting date1st January 2011

Contact informationDjamila Boerma (d.boerma@antoniusziekenhuis.nl)

NotesIt is unlikely that this trial will be included for the analysis since the intervention is performed after recovery. However, some participants may meet the inclusion criteria and we will try to get the information on such people.

NCT01687959

Trial name or titleTiming of laparoscopic cholecystectomy after endoscopic retrograde cholangiography for acute biliary pancreatitis

MethodsRandomised controlled trial

ParticipantsPatients with acute biliary pancreatitis

InterventionsEarly laparoscopic cholecystectomy (within 72 hours after endoscopic sphincterotomy versus delayed laparoscopic cholecystectomy (after 6 weeks)

OutcomesMortality and morbidity of laparoscopic cholecystectomy

Starting dateSeptember 2012

Contact informationMustafa Hasbahceci, Department of General Surgery; Bezmialem Vakif university Istanbul, Turkey, 34093

NotesSome patients with mild acute pancreatitis and all patients with acute severe pancreatitis will meet the inclusion criteria for this review.

 
Comparison 1. Early versus delayed laparoscopic cholecystectomy

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

 1 Serious adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Hospital stay1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Summary of findings for the main comparison. Early versus delayed laparoscopic cholecystectomy for mild acute pancreatitis

Early versus delayed laparoscopic cholecystectomy for mild acute pancreatitis

Patient or population: people with mild acute gallstone pancreatitis
Settings: secondary or tertiary care
Intervention: early laparoscopic cholecystectomy (within 3 days)
Comparison: delayed laparoscopic cholecystectomy (beyond 3 days)

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

Assumed riskCorresponding risk

Delayed laparoscopic cholecystectomy (beyond 72 hours)Early laparoscopic cholecystectomy (within 72 hours)

Serious adverse events40 per 100013 per 1000
(0 to 312)
RR 0.33
(0.01 to 7.81)
50
(1 study)
⊕⊝⊝⊝
very low1,2,3,4

Hospital stayThe mean hospital stay in the control groups was
5.8 days
The mean hospital stay in the intervention groups was
2.3 lower
(4.4 to 0.2 lower)
49
(1 study)
⊕⊕⊝⊝
low1,2

*The basis for the assumed risk is the control group risk. 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; RR: Risk 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 The trial was at high risk of bias.
2 There were too few trials to assess publication bias.
3 Overlaps 1 and 0.75 or 1.25.
4 The total number of events was fewer than 300.