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

Klempa 1995.

Methods Randomised controlled trial
Participants Country: Germany
Number randomised: 43
Post‐randomisation drop‐outs: not stated
Revised sample size: 43
Mean age (years): 47 years
Women: 10 (23.3%)
Follow‐up period (years): range 3‐5.5 years (mean not reported)
Number of study centres: 1
Inclusion criteria
  1. Ongoing chronic obstructive pancreatitis for multiple (3‐12) years with pain requiring analgesia or with severe pain as judged by independent investigators in a repeated manner (second opinion)

  2. Complications such as choledochostenosis causing jaundice, duodenal stenosis with stomach emptying disorders, compression of the duct of Wirsung in the head part of the organ, multiple pseudoaneurysm of the pancreatic head, transverse colon stenosis, segmental portal hypertension with compression of the superior mesenteric vein

Interventions Participants were randomly assigned to 1 of 2 groups
 Group 1: duodenum‐preserving pancreatoduodenectomy (n = 22)
 Further details: Beger procedure
 Group 2: pancreatoduodenectomy (n = 21)
 Further details: Whipple procedure
Outcomes Mortality, post‐operative complications, length of hospital stay, proportion of people employed, diabetes, and exocrine insufficiency
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "the patients according to the random number list (created prior to the study) were classified into two groups"
Allocation concealment (selection bias) Unclear risk Comment: this information was not available
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear 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 Unclear risk Comment: this information was not available
Selective reporting (reporting bias) Low risk Comment: all important outcomes were reported
Other bias Unclear risk Comment: it was not clear whether participants were excluded because of malignancy

CT: computed tomography; DPPHR: duodenum‐preserving pancreatic head resection; n: number of participants; PPPD: pylorus‐preserving pancreaticoduodenectomy.