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No Need for Routine Drainage after Pancreatoduodenectomy: the Dual Center Randomized Controlled PANDRA-Trial (ISRCTN04937707)
Helmut Witzigmann*1, Markus K. Diener*2, Stefan Kissenkötter*1, Inga Rossion*3, Thomas Bruckner*4, Bärbel Werner*5, Olaf Pridöhl*5, Olga Radulova-Mauersberger*5, Phillip Knebel*2, Oliver Strobel*2, Thilo Hackert*2, Markus W Buechler2
1Department of General-, Visceral- and Thoracic Surgery, Städtisches Krankenhaus Dresden-Friedrichstadt, Dresden, Germany2Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany3Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany4Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany5Department of General-, Visceral- and Thoracic Surgery, Staedtisches Krankenhaus Dresden-Friedrichstadt, Dresden, Germany

Objective
There is considerable uncertainty regarding intraabdominal drainage after pancreatoduodenectomy (Conlon 2001, VanBuren 2014). This randomized controlled, dual center (Heidelberg and Dresden), non-inferiority trial aimed to proof that omission of drains does not increase reintervention rate after pancreatic head resection.
Methods
Patients with pancreatic head tumors were randomized to intraabdominal drainage versus no-drain. Primary endpoint was overall reintervention rate (relaparotomy or radiologic intervention). Secondary endpoints were clinically relevant pancreatic fistulas (grade B/C), mortality, morbidity (bile leaks, delayed gastric emptying, wound infection, etc.) and hospital stay. Planned sample size was 188 patients per group, (assumed reintervention rate 12.5%; non-inferiority margin 8.5%). Analyses were done by intention to treat.
Results
438 patients were randomized and 42 patients (9.6%) were excluded as no pancreatic head resection was performed. 396 patients (205 drain, 191 no-drain) were analyzed. Overall in- hospital mortality (2.8%) was equal in both groups (drain 2.4 %, no drain 3.1%; p=0.67). Re-Intervention rates were significantly higher in the drainage group (drain 21.6%, no-drain 16.2%; p<0.01). Overall surgical morbidity (41.7%) was comparable (p=0.75). Pancreatic fistula rate (grade B/C only) was significantly reduced in the no-drain group (drain 11.9%, no-drain 5.8%; p=0.03). Operation time (p=0.09), postoperative bleeding (p=0.18), intra-abdominal abscess formation (p=0.22), burst abdomen (p=0.47), wound infection (p=0.71) and hospital stay (p=0.54) did not show significant differences.
Conclusions
Omission of drains was superior in terms of postoperative reintervention and clinically relevant pancreatic fistula rates. Prophylactic drains cannot be recommended during routine pancreatic head resections.


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