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

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

doi: 10.1097/SLA.0000000000000460
Feature

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.

This is the first randomized prospective multicenter trial to evaluate the outcome of pancreaticoduodenectomy (PD) with and without routine intraperitoneal drainage. This trial provides level 1 data suggesting that elimination of intraperitoneal drainage in all cases of PD increases the severity and frequency of complications.

*Baylor College of Medicine, The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, and The Dan L. Duncan Cancer Center, Houston, TX

Department of Surgery, The Ohio State University, Columbus, OH

Department of Surgery, University of Florida, Gainesville, FL

§Department of Surgery, Jefferson Medical College, Philadelphia, PA

Department of Surgery, Baptist Memorial Hospital/The University of Tennessee Health Science Center, Memphis, TN

Department of Surgery, Indiana University, Indianapolis, IN

**Department of Surgery, University of Pennsylvania, Philadelphia, PA

††Department of Surgery, University of South Florida, Tampa, FL; and

‡‡Department of Surgery, The University of Texas Medical Branch, Galveston, TX.

Reprints: William E. Fisher, MD, The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, 6620 Main St, Ste 1450, Houston, TX 77030. E-mail: wfisher@bcm.edu.

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Disclosure: This trial was funded by the Rodrick A. MacDonald Foundation (11RD1004) and partially funded by the Cancer Prevention and Research Institute of Texas (CPRIT) grant (RP101353) and the Dan L. Duncan Cancer Center Support grant (CA125123). The authors declare no conflicts of interest.

© 2014 by Lippincott Williams & Wilkins.