Abstract:
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.
journal_name
Trialsjournal_title
Trialsauthors
Pan SB,Geng W,Zhou DC,Chen JM,Zhao HC,Liu FB,Xie SX,Hou H,Zhao YJ,Xie K,Wang GB,Geng XPdoi
10.1186/s13063-016-1517-8subject
Has Abstractpub_date
2016-08-17 00:00:00pages
407issue
1issn
1745-6215pii
10.1186/s13063-016-1517-8journal_volume
17pub_type
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