One-layer Versus Two-layer Duet-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy:A Randomized Controlled Trial

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 thirteen patients included and randomized before pancreaticojejunal reconstruction and after resection of the lesion from the pancreatic or periampullary region.The primary efficacy endpoint is the 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.Results:Overall and clinically relevant rates of pancreatic fistula rates were 28.0%and 9.7%,respectively.Overall PF rates in the patients treated with one-layer vs two-layer duct-to-mucosa anastomoses were 25.0% vs 31.5%(p = 0.438),respectively and the corresponding clinically relevant PF rates were 3.6% vs 15.7%,respectively(p=0.028).Although the overall complication rates were similar in the two groups.One-layer duct-to-mucosa anastomosis was also associated with shorter postoperative hospital stay(12 vs 14 days;p =0.041).There was one perioperativedeath.Independent variables for the risk of PF were the diameter of the pancreatic duct(<3mm)and the underlying pathology.Discussion:This prospective,single-centre,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.The present study demonstrated that the application of theone-layer duct-to-mucosa anastomosis in PD did not decrease the overall incidence of pancreatic fistula;however,the incidence of clinically relevant pancreatic fistula was decreased.Trial Registration : This trial was registered with Clinical Trials.gov(identifier:NCT02511951)on 29 July 2015.