title: One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Clinical Trials.gov: NCT02511951 . Registered on 29 July 2015.
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Shu-Bo
authors.initials: SB
authors.lastname: Pan
authors.affiliation: Department of Liver Surgery, Ren Ji Hospital, School of Medicine Shanghai Jiao Tong University, No. 1630 Dongfang Road, Shanghai, 200127, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Geng
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Da-Chen
authors.initials: DC
authors.lastname: Zhou
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Jiang-Ming
authors.initials: JM
authors.lastname: Chen
authors.affiliation: Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Hong-Chuan
authors.initials: HC
authors.lastname: Zhao
authors.affiliation: Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Fu-Bao
authors.initials: FB
authors.lastname: Liu
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Sheng-Xue
authors.initials: SX
authors.lastname: Xie
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Hou
authors.affiliation: Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Yi-Jun
authors.initials: YJ
authors.lastname: Zhao
authors.affiliation: Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Kun
authors.initials: K
authors.lastname: Xie
authors.affiliation: Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Jixi Road 218#, Shushan District, Hefei, Anhui, 230022, China.
authors.forename: Guo-Bin
authors.initials: GB
authors.lastname: Wang
authors.affiliation: Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, Anhui, 230022, China. xp_geng@163.net.
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Geng
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D007413:Intestinal Mucosa / Q000601:surgery*; D007583:Jejunum / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010183:Pancreatic Ducts / Q000601:surgery*; D010185:Pancreatic Fistula / Q000209:etiology; D016577:Pancreaticoduodenectomy / Q000009:adverse effects; D010193:Pancreaticojejunostomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents; D013536:Suture Techniques; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Duct-to-mucosa; Pancreaticoduodenectomy; Pancreaticojejunostomy; Postoperative pancreatic fistula