title: No Need for Routine Drainage After Pancreatic Head Resection: The Dual-Center, Randomized, Controlled PANDRA Trial (ISRCTN04937707).
abstract: OBJECTIVE
  This dual-center, randomized, controlled, noninferiority trial aimed to prove that omission of drains does not increase reintervention rates after pancreatic surgery.
  
  
  BACKGROUND
  There is considerable uncertainty regarding intra-abdominal drainage after pancreatoduodenectomy.
  
  
  METHODS
  Patients undergoing pancreatic head resection with pancreaticojejunal anastomosis were randomized to intra-abdominal drainage versus no drainage. Primary endpoint was overall reintervention rate (relaparotomy or radiologic intervention). Secondary endpoints were clinically relevant pancreatic fistula (grade B/C), mortality, morbidity, and hospital stay. The planned sample size was 188 patients per group.
  
  
  RESULTS
  A total of 438 patients were randomized. Forty-three patients (9.8%) were excluded because no pancreatic anastomosis was performed, and 395 patients (202 drain, 193 no-drain) were analyzed. Reintervention rates were not inferior in the no-drain group (drain 21.3%, no-drain 16.6%; P = 0.0004). Overall in-hospital mortality (3.0%) was the same in both groups (drain 3.0%, no-drain 3.1%; P = 0.936). Overall surgical morbidity (41.8%) was comparable (P = 0.741). Clinically relevant pancreatic fistula (grade B/C: drain 11.9%, no-drain 5.7%; P = 0.030) and fistula-associated complications (drain 26.4%; no drain 13.0%; P = 0.0008) were significantly reduced in the no-drain group. Operation time (P = 0.093), postoperative hemorrhage (P = 0.174), intra-abdominal abscess formation (P = 0.199), biliary leakage (P = 0.382), delayed gastric emptying (P = 0.062), burst abdomen (P = 0.480), wound infection (P = 0.758), and hospital stay (P = 0.487) did not show significant differences.
  
  
  CONCLUSIONS
  Omission of drains was not inferior to intra-abdominal drainage in terms of postoperative reintervention and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. There is no need for routine prophylactic drainage after pancreatic resection with pancreaticojejunal anastomosis.
authors: *Department of General, Visceral, and Thoracic Surgery, Municipal Hospital Dresden-Friedrichstadt, Dresden †Department of General, Visceral, and Transplantation Surgery ‡Study Center of the German Surgical Society (SDGC) §Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
authors: Helmut
authors: H
authors: Witzigmann
authors: Markus K
authors: MK
authors: Diener
authors: Stefan
authors: S
authors: Kienkötter
authors: Inga
authors: I
authors: Rossion
authors: Thomas
authors: T
authors: Bruckner
authors: Bärbel Werner
authors: Olaf
authors: O
authors: Pridöhl
authors: Olga
authors: O
authors: Radulova-Mauersberger
authors: Heike
authors: H
authors: Lauer
authors: Phillip
authors: P
authors: Knebel
authors: Alexis
authors: A
authors: Ulrich
authors: Oliver
authors: O
authors: Strobel
authors: Thilo
authors: T
authors: Hackert
authors: Markus W
authors: MW
authors: Büchler
mesh_terms: D004322:Drainage; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D061646:Operative Time; D010179:Pancreas / Q000601:surgery*; D010185:Pancreatic Fistula / Q000209:etiology; D016577:Pancreaticoduodenectomy; D011183:Postoperative Complications; D012086:Reoperation; D012307:Risk Factors