title: Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula.
abstract: The aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure.
  
  
  
  Several studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump.
  
  
  
  One hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617).
  
  
  
  Sixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080).
  
  
  
  PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.
authors.affiliation: *Second Department of Surgery, Wakayama Medical University, Wakayama, Japan†Department of Surgery, Nara Medical University, Nara, Japan‡Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan§Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan||Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan¶Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Kawai
authors.forename: Seiko
authors.initials: S
authors.lastname: Hirono
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Okada
authors.forename: Masayuki
authors.initials: M
authors.lastname: Sho
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Nakajima
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Eguchi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
authors.forename: Hisashi
authors.initials: H
authors.lastname: Ikoma
authors.forename: Ryou
authors.initials: R
authors.lastname: Morimura
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Takeda
authors.forename: Shin
authors.initials: S
authors.lastname: Nakahira
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Suzumura
authors.forename: Jiro
authors.initials: J
authors.lastname: Fujimoto
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaue
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010180:Pancreatectomy / Q000009:adverse effects*; D010185:Pancreatic Fistula / Q000209:etiology* / Q000601:surgery*; D010190:Pancreatic Neoplasms / Q000601:surgery*; D010193:Pancreaticojejunostomy / Q000009:adverse effects; D011446:Prospective Studies; D012307:Risk Factors; D017792:Surgical Stapling; D013536:Suture Techniques; D016896:Treatment Outcome