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Blinding: no mention Follow‐up: adequate, withdrawn: n = 18 Dropouts: n = 0 Intention‐to‐treat analysis: no, used per‐protocol analysis Informed consent: described Sample size calculation: performed |
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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 |
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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) |
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Outcomes | The main outcome measures were: Mortality Pancreatic fistula Delayed gastric emptying DeOliveira's score Postoperative length of stay |
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Notes | All participants underwent PD, but 18 participants were withdrawn from the study before enrollment and randomization. 46 participants who completed the study were analyzed | |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Incomplete outcome data (attrition bias) All outcomes | Low risk | Detailed information, and withdrawn: n = 18 |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