Skip to main content
. 2016 May 6;2016(5):CD008914. doi: 10.1002/14651858.CD008914.pub3

Yokoyama 2014.

Methods Randomized controlled study
 Allocation sequence: not reported
 Allocation concealment: not reported
 Blinding: no mention
Follow‐up: adequate, withdrawn: n = 18
Dropouts: n = 0
 Intention‐to‐treat analysis: no, used per‐protocol analysis
Informed consent: described
 Sample size calculation: performed
Participants Country: Nagoya, Japan
Single center: Nagoya University Hospital, 64 participants were accrued between April 2006 and August 2008. 18 participants were excluded (4 due to local or liver metastasis, 2 due to dislocation of pancreatic tube, 1 due to re‐operation, 11 due to lass than 100ml discharge from pancreatic tube)
Non‐replacement of pancreatic duct drainage tube: Age: 63.3 (43 to 85) years; Gender: Male/Female: 15/9
Replacement of pancreatic duct drainage tube: Age: 63.1 (44 to 79) years; Gender: Male/Female: 13/9
Inclusion criteria: Underwent pancreaticoduodenectomies
Definition of pancreatic fistula: ISGPF and Classification of surgical complication after pancreatic surgery by DeOliveira 2006
Conflicts of interest: none
Interventions 64 participants were randomly assigned to 1 of 2 groups, excluded 18 participants:
Non‐replacement of pancreatic juice (n = 24)
Replacement of pancreatic juice (n = 22)
Outcomes The main outcome measures were:
Mortality
Pancreatic fistula
Delayed gastric emptying
DeOliveira's score
Postoperative length of stay
Notes All participants underwent PD, but 18 participants were withdrawn from the study before enrollment and randomization. 46 participants who completed the study were analyzed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk No mention, but "followed the method of a randomized controlled study"
Allocation concealment (selection bias) Unclear risk No mention
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No mention
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No mention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Detailed information, and withdrawn: n = 18
Selective reporting (reporting bias) Low risk No, according to results
Other bias Unclear risk None

CONSORT: Consolidated Standards of Reporting Trials
 ISGPF: International Study Group on Pancreatic Fistula
 PD: pancreaticoduodenectomy
 PJ: pancreaticojejunal