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Prophylactic gastrojejunostomy for unresectable periampullary carcinoma

  1. Kurinchi Selvan Gurusamy1,*,
  2. Senthil Kumar2,
  3. Brian R Davidson1

Editorial Group: Cochrane Upper GI and Pancreatic Diseases Group

Published Online: 28 FEB 2013

Assessed as up-to-date: 30 AUG 2012

DOI: 10.1002/14651858.CD008533.pub3


How to Cite

Gurusamy KS, Kumar S, Davidson BR. Prophylactic gastrojejunostomy for unresectable periampullary carcinoma. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD008533. DOI: 10.1002/14651858.CD008533.pub3.

Author Information

  1. 1

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

  2. 2

    Queens Hospital, Directorate of Surgery, Romford, Essex, UK

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

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 28 FEB 2013

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Characteristics of included studies [ordered by study ID]
Lillemoe 1999

MethodsRandomised controlled trial


ParticipantsCountry: USA.
Sample size: 87.
Post-randomisation drop-out: 0 (0%).
Revised sample size: 87.
Females: 37 (42.5%).
Mean age: 67 years.
Pancreatic cancer: 84 (96.6%).
Ampullary cancer: 0 (0%).
Duodenal cancer: 1 (1.1%).
Bile duct cancer: 2 (2.3%).
Biliary obstruction: 65 (74.7%).
Open or laparoscopic gastrojejunostomy: Open.
Histological confirmation: Yes.
Minimum follow-up: 6 months.
Biliary obstruction management: Hepaticojejunostomy.

Inclusion criteria:
Patients undergoing surgery for peri-ampullary cancer with intention to resect.
Exclusion criteria:
1. Resectable disease on laparotomy.
2. Considered to be at high risk of gastric outlet obstruction based on radiological features or intraoperative findings


InterventionsThe participants were randomly assigned to two groups.
Group 1: Gastrojejunostomy (n = 44).
Further details: a retrocolic gastrojejunostomy performed to the most dependent portion of the gastric antrum.
Group 2: No gastrojejunostomy (n = 43).

Patients with biliary tract obstruction underwent hepaticojejunostomy in both groups.


OutcomesThe outcomes reported were survival, peri-operative morbidity, gastric outlet obstruction, operating time, hospital stay.


NotesDefinition for gastric outlet obstruction: All patients had nausea and vomiting, with evidence of gastric outlet obstruction documented on endoscopy, upper gastrointestinal series, or computed tomography scan.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomized (using a computer-generated random number pattern)".

Blinding (performance bias and detection bias)
All outcomes
High risk

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: There were no post-randomisation drop-outs.

Selective reporting (reporting bias)Low riskComment: All important outcomes were reported.

Free of baseline imbalance bias?Low riskComment: Patients were well matched for important prognostic factors.

Van Heek 2003

MethodsRandomised controlled trial


ParticipantsCountry: Netherlands.
Sample size: 70.
Post-randomisation drop-out: 5 (7.1%).
Revised sample size: 65.
Females: 30 (46.2%).
Mean age: 64 years.
Pancreatic cancer: 57 (87.7%).
Ampullary cancer: 2 (3.1%).
Duodenal cancer: 0 (0%).
Bile duct cancer: 6 (9.2%).
Biliary obstruction: 51 (78.5%).
Open or laparoscopic gastrojejunostomy: Open.
Histological confirmation: Yes.
Minimum follow-up: 9 months.
Biliary obstruction management: Hepaticojejunostomy.

Inclusion criteria:
Patients undergoing surgery for peri-ampullary cancer with intention to resect.
Exclusion criteria:
Resectable disease on laparotomy.


InterventionsThe participants were randomly assigned to two groups.
Group 1: Gastrojejunostomy (n = 36).
Further details: retrocolic.
Group 2: No gastrojejunostomy (n = 29).
Co-interventions:
All patients underwent hepaticojejunostomy irrespective of biliary tract obstruction


OutcomesThe outcomes reported were survival, peri-operative morbidity, gastric outlet obstruction, hospital stay, and quality of life.


NotesReasons for post-randomisation drop-out: 1 patient benign; 1 patient became resectable after frozen section; 3 patients lost to follow-up.

Gastric outlet obstruction was defined as clinical symptoms of obstruction, such as nausea and vomiting, in combination with radiologic or endoscopic proof of gastric retention or stenosis.


Risk of bias

BiasAuthors' judgementSupport for judgement

Blinding (performance bias and detection bias)
All outcomes
High risk

Incomplete outcome data (attrition bias)
All outcomes
High riskComment: Post-randomisation drop-outs could influence the effect estimate.

Selective reporting (reporting bias)Low riskComment: All important outcomes were reported.

Free of baseline imbalance bias?Low riskComment: Patients were well matched for important prognostic factors.

Free of early stopping bias?High riskComment: The trial was stopped early.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Cho 2008Not a randomised controlled trial.

Lillemoe 2004Not a randomised controlled trial.

Tandon 1999Not a randomised controlled trial.

 
Comparison 1. Prophylactic gastrojejunostomy for unresectable periampullary carcinoma

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

 1 Survival2Hazard Ratio (Fixed, 95% CI)1.02 [0.84, 1.25]

 2 Peri-operative morbidity2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    2.1 Peri-operative mortality
2152Risk Ratio (M-H, Fixed, 95% CI)2.43 [0.10, 57.57]

    2.2 Cholangitis
187Risk Ratio (M-H, Fixed, 95% CI)1.95 [0.38, 10.12]

    2.3 Bile leak
2152Risk Ratio (M-H, Fixed, 95% CI)1.23 [0.29, 5.27]

    2.4 Gastroenteral leak
2152Risk Ratio (M-H, Fixed, 95% CI)0.81 [0.05, 12.33]

    2.5 Delayed gastric emptying
2152Risk Ratio (M-H, Fixed, 95% CI)2.99 [0.63, 14.23]

    2.6 Wound infection
2152Risk Ratio (M-H, Fixed, 95% CI)3.19 [0.55, 18.59]

    2.7 Chest complications
2152Risk Ratio (M-H, Fixed, 95% CI)0.44 [0.08, 2.34]

    2.8 Cardiac complications
165Risk Ratio (M-H, Fixed, 95% CI)1.61 [0.32, 8.19]

 3 Quality of lifeOther dataNo numeric data

 4 Gastric outlet obstruction2152Risk Ratio (M-H, Fixed, 95% CI)0.10 [0.03, 0.37]

 5 Operating time187Mean Difference (IV, Fixed, 95% CI)45.0 [21.39, 68.61]

 6 Hospital stay2152Mean Difference (IV, Fixed, 95% CI)0.97 [-0.18, 2.12]

 
Analysis 1.3 Comparison 1 Prophylactic gastrojejunostomy for unresectable periampullary carcinoma, Outcome 3 Quality of life.
Quality of life

Study

Van Heek 2003There was no difference in the quality of life between the two groups at any time point.

 
Summary of findings for the main comparison. Prophylactic gastrojejunostomy for unresectable periampullary carcinoma

Prophylactic gastrojejunostomy for unresectable periampullary carcinoma

Patient or population: patients with unresectable periampullary carcinoma
Settings: inpatients
Intervention: Prophylactic gastrojejunostomy

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

Assumed riskCorresponding risk

ControlProphylactic gastrojejunostomy

Survival
Follow-up: 6 to 9 months
40 per 100141 per 100
(35 to 48)1
HR 1.02
(0.84 to 1.25)
152
(2 studies)
⊕⊝⊝⊝
very low2,3
There was no difference in the long-term survival between the patients undergoing prophylactic gastrojejunostomy and those who did not.

Gastric outlet obstruction
Clinical symptoms of vomiting with confirmation of the gastric outlet obstruction by radiological or endoscopic investigations
Follow-up: 6 months
28 per 1003 per 100
(1 to 10)
RR 0.1
(0.03 to 0.37)
152
(2 studies)
⊕⊝⊝⊝
very low2,3,4
Gastric outlet obstruction was significantly reduced in those undergoing gastrojejunostomy.

Operating timeThe mean operating time in the control groups was
209 minutes
The mean operating time in the intervention groups was
45 minutes longer
(21.39 to 68.61 longer)
87
(1 study)
⊕⊝⊝⊝
very low2,3,4
The operating time was 45 minutes longer in the gastrojejunostomy group than the control group.

*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; RR: Risk ratio; HR: Hazard 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 At six to nine months approximately 40% of patients in the control group were dead. This is equivalent to about 29 patients. Since all the included patients were followed until death, there was no censoring of patients and the figure is of actual survival of patients rather than actuarial survival.
2 Three patients in one trial were excluded from the trial report because of loss to follow-up.
3 Small numbers of events
4 The existence or method of blinding was not reported in either trial.