title: Papillary-like main pancreatic duct invaginated pancreaticojejunostomy versus duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: A prospective randomized trial.
abstract: BACKGROUND
  Development of a postoperative pancreatic fistula (POPF) is the single most significant complication of pancreatic anastomosis, which is a key procedure in pancreaticoduodenectomy. We previously reported a new papillary-like pancreaticojejunostomy, and a retrospective study showed a benefit in reducing the incidence of grade B/C POPF compared with duct-to-mucosa pancreaticojejunostomy. The aim of this study was to reassess whether the new pancreaticojejunostomy would decrease the POPF rate.
  
  
  METHODS
  A prospective, randomized, controlled trial (NCT01731821 registered at http://ClinicalTrials.gov) involving 308 patients who underwent pancreaticoduodenectomy was conducted.
  
  
  RESULTS
  The overall POPF rate was significantly lower in the papillary-like group compared with the duct-to-mucosa group (14/155 [9.0%] vs 31/153 [20.3%]; P = .005), and the grade B/C POPF rate of the papillary-like group was significantly decreased compared with the duct-to-mucosa group. Multivariable analyses identified higher body mass index (odds ratio [OR], 3.520; P = .000), longer operative time (OR, 2.587; P = .041), soft texture and nondilated main pancreatic duct (OR, 0.365; P = .014), and the duct-to-mucosa pancreaticojejunostomy (OR, 0.405; P = .013) as significant risk factors for POPF. Further stratified analyses showed that, for patients with soft texture and nondilated main pancreatic duct, the POPF rate in the papillary-like group (9.6%) was significantly lower than that in the duct-to-mucosa group (27.3%). However, for patients with hard texture or dilated main pancreatic duct, there was no difference between the 2 groups (7.8% vs 8.6%; P > 0.999).
  
  
  CONCLUSIONS
  The new papillary-like pancreaticojejunostomy may provide a better option for patients with soft texture and nondilated main pancreatic duct.
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Xu
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Si
authors.initials: S
authors.lastname: Shi
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Qin
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Shunrong
authors.initials: S
authors.lastname: Ji
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Wenyan
authors.initials: W
authors.lastname: Xu
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Liang
authors.initials: L
authors.lastname: Liu
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Chen
authors.initials: C
authors.lastname: Liu
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Jiang
authors.initials: J
authors.lastname: Long
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China.
authors.forename: Quanxing
authors.initials: Q
authors.lastname: Ni
authors.affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China. Electronic address: yuxianjun88@hotmail.com.
authors.forename: Xianjun
authors.initials: X
authors.lastname: Yu
mesh_terms: D000368:Aged; D015992:Body Mass Index; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010185:Pancreatic Fistula / Q000209:etiology* / Q000517:prevention & control*; D010190:Pancreatic Neoplasms / Q000150:complications / Q000473:pathology / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D010193:Pancreaticojejunostomy / Q000009:adverse effects* / Q000379:methods*; D011446:Prospective Studies; D016896:Treatment Outcome