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. 2016 Feb 3;2016(2):CD011521. doi: 10.1002/14651858.CD011521.pub2

Buchler 1995.

Methods Randomised controlled trial
Participants Country: Germany
Number randomised: 48
Post‐randomisation drop‐outs: 8 (16.7%)
Revised sample size: 40
Mean age (years): 45
Women: 4 (10%)
Follow‐up period (years): 14
Number of study centres: 1
Inclusion criteria
  1. People were enrolled in the study when they presented with pancreatic head enlargement defined as a diameter of > 4 cm in contrast‐enhanced CT scan

  2. Obstruction of the common bile or pancreatic duct or duodenum

  3. Entrapment of the retroperitoneal portal vein or superior mesenteric artery

  4. General condition suitable for either a DPPHR or a Whipple procedure

Interventions Participants were randomly assigned to 1 of 2 groups
 Group 1: duodenum‐preserving pancreatoduodenectomy (n = 20) (23 participants were randomised)
 Further details: Beger procedure
 Group 2: pancreatoduodenectomy (n = 20) (25 participants were randomised)
 Further details: Whipple procedure
Outcomes Mortality, post‐operative complications, quality of life, length of hospital stay, proportion of people employed, diabetes, and exocrine insufficiency
Notes Reasons for post‐randomisation drop‐outs: pancreatic cancer (n = 1), did not require pancreatic head resection (n = 7)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available
Allocation concealment (selection bias) Unclear risk Comment: this information was not available
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: information on participant blinding was not available. It is impossible to blind surgeons who perform the procedure
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: this information was not available
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no participants were lost to follow‐up, although some participants were excluded from analysis (see other bias)
Selective reporting (reporting bias) Low risk Comment: all important outcomes were reported
Other bias High risk Comment: 1 participant had pancreatic cancer intra‐operatively and underwent Whipple procedure. The group to which this participant was randomised was not stated. 7 other participants were excluded from the analysis since they did not require pancreatic head resection. All the participants were symptomatic. Therefore, the reason for abandoning surgeries was not clear