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One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial
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One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial
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One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial
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Journal Article
One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial
2016
Overview
Background
Although various pancreaticojejunal duct-to-mucosa anastomosis methods have been developed to reduce the postoperative risks of pancreaticoduodenectomy, pancreatic fistula remains the most serious complication with a high incident rate. The aim of this study is to compare the safety and effectiveness of one-layer and two-layer duct-to-mucosa pancreaticojejunostomy in patients undergoing pancreaticoduodenectomy.
Methods/design
In this study, adult patients who sign consent forms will be recruited and scheduled for elective pancreaticoduodenectomy. One hundred and fourteen patients will be included and randomized before pancreaticojejunal reconstruction and after resection of the lesion from the pancreatic or periampullary region. The primary efficacy endpoint is the incident rate of postoperative pancreatic fistula. Statistical analysis will be based on the intention-to-treat population. Patients will be followed up for 3 months by monitoring for complications and other adverse events.
Discussion
This prospective, single-center, randomized, single-blinded, two-group parallel trial is designed to compare one-layer with two-layer duct-to-mucosa anastomosis for pancreaticojejunal anastomosis during elective pancreaticoduodenectomy.
Trial registration
Clinical Trials.gov:
NCT02511951
. Registered on 29 July 2015.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Adult
/ Aged
/ Analysis
/ China
/ Consent
/ Female
/ Fistula
/ Humans
/ Male
/ Medicine
/ Pancreas
/ Pancreatic Fistula - etiology
/ Pancreaticoduodenectomy - adverse effects
/ Pancreaticojejunostomy - adverse effects
/ Pancreaticojejunostomy - instrumentation
/ Pancreaticojejunostomy - methods
/ Patients
/ Statistics for Life Sciences
/ Stents
/ Sutures
