Farkas 2006.

Methods	Randomised controlled trial
Participants	Country: Hungary Number randomised: 45. Post‐randomisation drop‐outs: 5 (11.1%) Revised sample size: 40 Mean age (years): 44 Women: 10 (25%) Follow‐up period (years): 1 Number of study centres: 1 Inclusion criteria Pancreatic head enlargement, defined as a diameter of > 4 cm in a contrast‐enhanced CT scan Intractable pain and obstruction of the common bile or pancreatic duct or duodenum Exclusion criteria Myocardial infarction within the previous 6 months Detection of a malignant pancreatic tumour
Interventions	Participants were randomly assigned to 1 of 2 groups Group 1: duodenum‐preserving pancreatoduodenectomy (n = 20) (23 participants were randomised) Further details: wide local excision of head of pancreas Group 2: pancreatoduodenectomy (n = 20) (22 participants were randomised) Further details: PPPD
Outcomes	Mortality, post‐operative complications, length of hospital stay, and diabetes
Notes	Reasons for post‐randomisation drop‐outs: pancreatic carcinoma confirmed by histological examination of a frozen section intraoperatively.
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	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	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: participants were excluded because they were found to have pancreatic cancer intraoperatively. This can introduce bias since the intervention (duodenum‐preserving pancreatoduodenectomy) is a less invasive procedure than control (pancreatoduodenectomy)