title: Pancreatogastrostomy versus pancreatojejunostomy for RECOnstruction after partial PANCreatoduodenectomy (RECOPANC): study protocol of a randomized controlled trial UTN U1111-1117-9588.
abstract: BACKGROUND
  Pancreatoduodenectomy is one of the most complex abdominal operations, usually performed for tumors of the periampullary region and chronic pancreatitis. Leakage of pancreatic juice from the pancreatoenteric anastomosis, called postoperative pancreatic fistula, is the most prominent postoperative complication. Retrospective studies show a significant reduction of fistula rates with pancreatogastrostomy as compared to pancreatojejunostomy, the most frequently employed method of pancreatoenterostomy. Most single-center prospective trials, however, have not validated this finding. A large multicenter trial is needed for clarification.
  
  
  METHODS
  RECOPANC is a prospective, randomized, controlled multicenter trial with two treatment arms, pancreatogastrostomy versus pancreatojejunostomy. The trial hypothesis is that postoperative pancreatic fistula rate is lower after pancreatogastrostomy when compared to pancreatojejunostomy. Fourteen academic centers for pancreatic surgery will participate to allocate 360 patients to the trial. The duration of the entire trial is four years including prearrangement and analyses.
  
  
  CONCLUSIONS
  Postoperative pancreatic fistula is the main reason for clinically important postoperative morbidity after pancreatoduodenectomy. The primary goal of the chosen reconstruction technique for pancreatoenteric anastomosis is to minimize postoperative fistula rate. A randomized trial performed at multiple high-volume centers for pancreatic surgery is the best opportunity to investigate one of the most crucial issues in pancreatic surgery.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS00000767 (2011/03/23), FSI 2011/05/31. Universal Trial Number U1111-1117-9588.
authors.affiliation: Department of General and Visceral Surgery, Freiburg, Germany.
authors.forename: Ulrich Friedrich
authors.initials: UF
authors.lastname: Wellner
authors.forename: Sabine
authors.initials: S
authors.lastname: Brett
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Ronald
authors.initials: R
authors.lastname: Limprecht
authors.forename: Inga
authors.initials: I
authors.lastname: Rossion
authors.forename: Christoph
authors.initials: C
authors.lastname: Seiler
authors.forename: Olivia
authors.initials: O
authors.lastname: Sick
authors.forename: Inga
authors.initials: I
authors.lastname: Wegener
authors.forename: Ulrich Theodor
authors.initials: UT
authors.lastname: Hopt
authors.forename: Tobias
authors.initials: T
authors.lastname: Keck
mesh_terms: D000046:Academic Medical Centers; D005774:Gastrostomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005858:Germany; D006801:Humans; D010185:Pancreatic Fistula / Q000209:etiology; D016577:Pancreaticoduodenectomy / Q000009:adverse effects / Q000401:mortality; D010193:Pancreaticojejunostomy / Q000009:adverse effects / Q000401:mortality; D011446:Prospective Studies; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome