Pessaux 2011.

Methods	Randomized clinical trial (registered at www.clinicaltrials.gov, ID# NCT01068886) Allocation sequence: central random numbers Allocation concealment: sealed envelopes. We considered both allocation sequence generation and allocation concealment to be adequate. Blinding: not mentioned Follow‐up: adequate. All participants were reviewed 6 weeks after operation to complete the follow‐up. Dropouts: n = 0 Informed consent: reported Intention‐to‐treat analysis: used Sample size calculation: not performed
Participants	Country: Strasbourg, France Multicenter, between January 2006 and March 2009 No. randomized: 158 Age: No‐stent group: 60.6 ± 11.8 years; Stent group: 60.8 ± 11.8 years Gender: Male/Female: 86/72 Inclusion criteria: Participants underwent conventional or pylorus‐preserving PD Exclusion criteria: Age less than 18 years, emergency surgery Definition of pancreatic fistula: ISGPF Conflicts of interest: No potential conflicts of interest
Interventions	158 participants who underwent PD were randomized intraoperatively to either receive an external stent inserted across the anastomosis to drain the pancreatic duct (n = 77) or no stent (n = 81)
Outcomes	The main outcome measures were: Pancreatic fistula Overall morbidity rate Mortality rate Length of hospitalization
Notes	None
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central random numbers
Allocation concealment (selection bias)	Unclear risk	Sealed envelopes
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not mentioned
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not mentioned
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reported
Selective reporting (reporting bias)	Low risk	According to the detailed outcomes
Other bias	Unclear risk	None detailed