Details

Autor(en) / Beteiligte

• Witzigmann, Helmut
• Diener, Markus K
• Kienkötter, Stefan
• Rossion, Inga
• Bruckner, Thomas
• Bärbel Werner
• Pridöhl, Olaf
• Radulova-Mauersberger, Olga
• Lauer, Heike
• Knebel, Phillip
• Ulrich, Alexis
• Strobel, Oliver
• Hackert, Thilo
• Büchler, Markus W

Titel

No Need for Routine Drainage After Pancreatic Head Resection: The Dual-Center, Randomized, Controlled PANDRA Trial (ISRCTN04937707)

Ist Teil von

• Annals of surgery, 2016-09, Vol.264 (3), p.528-537

Ort / Verlag

United States: Copyright Wolters Kluwer Health, Inc. All rights reserved

Erscheinungsjahr

2016

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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/Cdrain 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.