title: Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial.
abstract: BACKGROUND
  The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant.
  
  
  METHODS
  This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029.
  
  
  RESULTS
  Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0·84, 95% CI 0·53–1·33; p=0·56). One patient died within the fi rst 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups.
  
  
  CONCLUSIONS
  Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome.
  
  
  BACKGROUND
  German Federal Ministry of Education and Research.
authors.affiliation: Study Centre of the German Surgical Society and Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Seiler
authors.forename: Inga
authors.initials: I
authors.lastname: Rossion
authors.forename: Jörg
authors.initials: J
authors.lastname: Kleeff
authors.forename: Matthias
authors.initials: M
authors.lastname: Glanemann
authors.forename: Giovanni
authors.initials: G
authors.lastname: Butturini
authors.forename: Ales
authors.initials: A
authors.lastname: Tomazic
authors.forename: Christiane J
authors.initials: CJ
authors.lastname: Bruns
authors.forename: Olivier R C
authors.initials: OR
authors.lastname: Busch
authors.forename: Stefan
authors.initials: S
authors.lastname: Farkas
authors.forename: Orlin
authors.initials: O
authors.lastname: Belyaev
authors.forename: John P
authors.initials: JP
authors.lastname: Neoptolemos
authors.forename: Christopher
authors.initials: C
authors.lastname: Halloran
authors.forename: Tobias
authors.initials: T
authors.lastname: Keck
authors.forename: Marco
authors.initials: M
authors.lastname: Niedergethmann
authors.forename: Klaus
authors.initials: K
authors.lastname: Gellert
authors.forename: Helmut
authors.initials: H
authors.lastname: Witzigmann
authors.forename: Otto
authors.initials: O
authors.lastname: Kollmar
authors.forename: Peter
authors.initials: P
authors.lastname: Langer
authors.forename: Ulrich
authors.initials: U
authors.lastname: Steger
authors.forename: Jens
authors.initials: J
authors.lastname: Neudecker
authors.forename: Frederik
authors.initials: F
authors.lastname: Berrevoet
authors.forename: Silke
authors.initials: S
authors.lastname: Ganzera
authors.forename: Markus M
authors.initials: MM
authors.lastname: Heiss
authors.forename: Steffen P
authors.initials: SP
authors.lastname: Luntz
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control; D011183:Postoperative Complications; D012306:Risk; D017792:Surgical Stapling; D013536:Suture Techniques