Annals of Surgery. 259(4):605–612, APRIL 2014

DOI: 10.1097/SLA.0000000000000460

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PMID: 24374513

Issn Print: 0003-4932

Publication Date: April 2014


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A Randomized Prospective Multicenter Trial of Pancreaticoduodenectomy With and Without Routine Intraperitoneal Drainage

George Van Buren;Mark Bloomston;Steven Hughes;Jordan Winter;Stephen Behrman;Nicholas Zyromski;Charles Vollmer;Vic Velanovich;Taylor Riall;Peter Muscarella;Jose Trevino;Attila Nakeeb;C. Schmidt;Kevin Behrns;E. Ellison;Omar Barakat;Kyle Perry;Jeffrey Drebin;Michael House;Sherif Abdel-Misih;Eric Silberfein;Steven Goldin;Kimberly Brown;Somala Mohammed;Sally Hodges;Amy McElhany;Mehdi Issazadeh;Eunji Jo;Qianxing Mo;William Fisher;

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Abstract

Objective:To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications.Background:Some surgeons have abandoned the use of drains placed during pancreas resection.Methods:We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups.Results:There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage.Conclusions:This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.

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