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A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and without Routine Intraperitoneal Drainage
George Van Buren, II1, Mark Bloomston*2, Carl R. Schmidt*2, Stephen W. Behrman*3, Nicholas J. Zyromski*4, Chad G. Ball*5, Katherine A. Morgan*6, Steve J. Hughes*7, Paul J. Karanicolas*8, John D. Allendorf*9, Charles M. Vollmer, Jr.10, Quan Ly*11, Kimberly M. Brown12, Vic Velanovich13, Jordan M. Winter*14, Amy L. McElhany1, Peter Muscarella, II*2, C. Max Schmidt4, Michael G. House*4, Elijah Dixon5, Mary E. Dillhoff*2, Jose G. Trevino15, Julie Hallet*8, Natalie S.G. Coburn*8, Atilla Nakeeb*4, Kevin E. Behrns15, Aaron R. Sasson*11, Eugene P. Ceppa*4, Sherif R.Z. Abdel-Misih*2, Taylor S. Riall12, Eric J. Silberfein1, E. Christopher Ellison2, David B. Adams6, Cary Hsu1, Hop S. Tran Cao1, Somala Mohammed1, Nicole Villafaņe Ferriol1, Omar Barakat1, Nader Massarweh1, Christy Chai1, J. Euberto Mendez1, Andrew Fang1, Eunji Jo1, Mo Qianxing1, William E. Fisher1
1Baylor College of Medicine, Houston, TX;2The Ohio State University, Columbus, OH;3Baptist Memorial Hospital/University of Tennessee Health Science Center, Memphis, TN;4Indiana University, Indianapolis, IN;5University of Calgary, Calgary, AB, Canada6Medical University of South Carolina, Charleston, SC;7University of Florida, Gainesville, TX;8Sunnybrook Health Sciences Centre, Toronto, ON, Canada9Winthrop University Hospital, Mineola, NY;10University of Pennsylvania, Philadelphia, PA;11University of Nebraska Medical Center, Omaha, NE;12The University of Texas Medical Branch, Galveston, TX;13University of South Florida, Tampa, FL;14Thomas Jefferson University, Philadelphia, PA;15University of Florida, Gainesville, FL

OBJECTIVE(S): The use of routine intraperitoneal drains during distal pancreatectomy (DP) is controversial. The objective of this study was to test the hypothesis that DP without intraperitoneal drainage does not affect the frequency or severity of complications.
METHODS: Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 10% positive or negative difference in number of ≥ grade 2 complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy.
RESULTS: 344 patients underwent DP with (n=174) and without (n=170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the number of patients with at least one ≥ grade 2 complication (76/44% vs. 72/42%, p= 0.80) or mortality (0/0% vs. 2/1%, p= 0.24). There was no difference in clinically relevant postoperative pancreatic fistula (31/18% vs. 20/12%, p= 0.11). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (18/10% vs. 41/24%, p=0.001). There was no difference in percutaneous drain placement, reoperation, readmission, or quality of life scores.
CONCLUSIONS: This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.

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