A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage

George Van Buren; Mark Bloomston; Carl R. Schmidt; Stephen W. Behrman; Nicholas J. Zyromski; Chad G. Ball; Katherine A. Morgan; Steven J. Hughes; Paul J. Karanicolas; John D. Allendorf; Charles M. Vollmer; Quan Ly; Kimberly M. Brown; Vic Velanovich; Jordan M. Winter; Amy L. McElhany; Peter Muscarella; Christian Max Schmidt; Michael G. House; Elijah Dixon; Mary E. Dillhoff; Jose G. Trevino; Julie Hallet; Natalie S.G. Coburn; Attila Nakeeb; Kevin E. Behrns; Aaron R. Sasson; Eugene P. Ceppa; Sherif R.Z. Abdel-Misih; Taylor S. Riall; Eric J. Silberfein; Edwin C. Ellison; David B. Adams; Cary Hsu; Hop S.Tran Cao; Somala Mohammed; Nicole Villafañe-Ferriol; Omar Barakat; Nader N. Massarweh; Christy Chai; Jose E. Mendez-Reyes; Andrew Fang; Eunji Jo; Qianxing Mo; William E. Fisher

doi:10.1097/SLA.0000000000002375

A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage

George Van Buren
, Mark Bloomston
, Carl R. Schmidt
, Stephen W. Behrman
, Nicholas J. Zyromski
, Chad G. Ball
, Katherine A. Morgan
, Steven J. Hughes
, Paul J. Karanicolas
, John D. Allendorf
, Charles M. Vollmer
, Quan Ly
, Kimberly M. Brown
, Vic Velanovich
, Jordan M. Winter
, Amy L. McElhany
, Peter Muscarella
, Christian Max Schmidt
, Michael G. House
, Elijah Dixon

Mary E. Dillhoff, Jose G. Trevino, Julie Hallet, Natalie S.G. Coburn, Attila Nakeeb, Kevin E. Behrns, Aaron R. Sasson, Eugene P. Ceppa, Sherif R.Z. Abdel-Misih, Taylor S. Riall, Eric J. Silberfein, Edwin C. Ellison, David B. Adams, Cary Hsu, Hop S.Tran Cao, Somala Mohammed, Nicole Villafañe-Ferriol, Omar Barakat, Nader N. Massarweh, Christy Chai, Jose E. Mendez-Reyes, Andrew Fang, Eunji Jo, Qianxing Mo, William E. Fisher

Surgery

Baylor College of Medicine
Dan L. Duncan Cancer Center
Ohio State University
University of Tennessee Health Science Center
Indiana University-Purdue University Indianapolis
University of Calgary
Medical University of South Carolina
University of Florida
University of Toronto
Winthrop-University Hospital
University of Pennsylvania
University of Nebraska Medical Center
University of Texas Medical Branch at Galveston
University of South Florida
Thomas Jefferson University

Research output: Contribution to journal › Article › peer-review

140 Scopus citations

Abstract

Objective: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Background: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. 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 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. Results: A total of 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 rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, 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.

Original language	English
Pages (from-to)	421-431
Number of pages	11
Journal	Annals of Surgery
Volume	266
Issue number	3
DOIs	https://doi.org/10.1097/SLA.0000000000002375
State	Published - Sep 1 2017

Keywords

distal pancreatectomy
intraperitoneal drain
multicenter
randomized controlled trial

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10.1097/SLA.0000000000002375

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Van Buren, G., Bloomston, M., Schmidt, C. R., Behrman, S. W., Zyromski, N. J., Ball, C. G., Morgan, K. A., Hughes, S. J., Karanicolas, P. J., Allendorf, J. D., Vollmer, C. M., Ly, Q., Brown, K. M., Velanovich, V., Winter, J. M., McElhany, A. L., Muscarella, P., Schmidt, C. M., House, M. G., ... Fisher, W. E. (2017). A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage. Annals of Surgery, 266(3), 421-431. https://doi.org/10.1097/SLA.0000000000002375

@article{c2a29d95bd89418eb89a55c8b5094edc,

title = "A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage",

abstract = "Objective: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Background: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. 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 15\% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. Results: A total of 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 rate of grade 2 or higher grade complications (44\% vs. 42\%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18\% vs 12\%, P = 0.11) or mortality (0\% vs 1\%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9\% vs 22\%, P = 0.0004). There was no difference in the frequency of postoperative imaging, 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.",

keywords = "distal pancreatectomy, intraperitoneal drain, multicenter, randomized controlled trial",

author = "\{Van Buren\}, George and Mark Bloomston and Schmidt, \{Carl R.\} and Behrman, \{Stephen W.\} and Zyromski, \{Nicholas J.\} and Ball, \{Chad G.\} and Morgan, \{Katherine A.\} and Hughes, \{Steven J.\} and Karanicolas, \{Paul J.\} and Allendorf, \{John D.\} and Vollmer, \{Charles M.\} and Quan Ly and Brown, \{Kimberly M.\} and Vic Velanovich and Winter, \{Jordan M.\} and McElhany, \{Amy L.\} and Peter Muscarella and Schmidt, \{Christian Max\} and House, \{Michael G.\} and Elijah Dixon and Dillhoff, \{Mary E.\} and Trevino, \{Jose G.\} and Julie Hallet and Coburn, \{Natalie S.G.\} and Attila Nakeeb and Behrns, \{Kevin E.\} and Sasson, \{Aaron R.\} and Ceppa, \{Eugene P.\} and Abdel-Misih, \{Sherif R.Z.\} and Riall, \{Taylor S.\} and Silberfein, \{Eric J.\} and Ellison, \{Edwin C.\} and Adams, \{David B.\} and Cary Hsu and Cao, \{Hop S.Tran\} and Somala Mohammed and Nicole Villafa{\~n}e-Ferriol and Omar Barakat and Massarweh, \{Nader N.\} and Christy Chai and Mendez-Reyes, \{Jose E.\} and Andrew Fang and Eunji Jo and Qianxing Mo and Fisher, \{William E.\}",

year = "2017",

month = sep,

day = "1",

doi = "10.1097/SLA.0000000000002375",

language = "English",

volume = "266",

pages = "421--431",

journal = "Annals of Surgery",

issn = "0003-4932",

number = "3",

}

Van Buren, G, Bloomston, M, Schmidt, CR, Behrman, SW, Zyromski, NJ, Ball, CG, Morgan, KA, Hughes, SJ, Karanicolas, PJ, Allendorf, JD, Vollmer, CM, Ly, Q, Brown, KM, Velanovich, V, Winter, JM, McElhany, AL, Muscarella, P, Schmidt, CM, House, MG, Dixon, E, Dillhoff, ME, Trevino, JG, Hallet, J, Coburn, NSG, Nakeeb, A, Behrns, KE, Sasson, AR, Ceppa, EP, Abdel-Misih, SRZ, Riall, TS, Silberfein, EJ, Ellison, EC, Adams, DB, Hsu, C, Cao, HST, Mohammed, S, Villafañe-Ferriol, N, Barakat, O, Massarweh, NN, Chai, C, Mendez-Reyes, JE, Fang, A, Jo, E, Mo, Q & Fisher, WE 2017, 'A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage', Annals of Surgery, vol. 266, no. 3, pp. 421-431. https://doi.org/10.1097/SLA.0000000000002375

TY - JOUR

T1 - A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage

AU - Van Buren, George

AU - Bloomston, Mark

AU - Schmidt, Carl R.

AU - Behrman, Stephen W.

AU - Zyromski, Nicholas J.

AU - Ball, Chad G.

AU - Morgan, Katherine A.

AU - Hughes, Steven J.

AU - Karanicolas, Paul J.

AU - Allendorf, John D.

AU - Vollmer, Charles M.

AU - Ly, Quan

AU - Brown, Kimberly M.

AU - Velanovich, Vic

AU - Winter, Jordan M.

AU - McElhany, Amy L.

AU - Muscarella, Peter

AU - Schmidt, Christian Max

AU - House, Michael G.

AU - Dixon, Elijah

AU - Dillhoff, Mary E.

AU - Trevino, Jose G.

AU - Hallet, Julie

AU - Coburn, Natalie S.G.

AU - Nakeeb, Attila

AU - Behrns, Kevin E.

AU - Sasson, Aaron R.

AU - Ceppa, Eugene P.

AU - Abdel-Misih, Sherif R.Z.

AU - Riall, Taylor S.

AU - Silberfein, Eric J.

AU - Ellison, Edwin C.

AU - Adams, David B.

AU - Hsu, Cary

AU - Cao, Hop S.Tran

AU - Mohammed, Somala

AU - Villafañe-Ferriol, Nicole

AU - Barakat, Omar

AU - Massarweh, Nader N.

AU - Chai, Christy

AU - Mendez-Reyes, Jose E.

AU - Fang, Andrew

AU - Jo, Eunji

AU - Mo, Qianxing

AU - Fisher, William E.

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Objective: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Background: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. 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 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. Results: A total of 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 rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, 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.

AB - Objective: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. Background: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. 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 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. Results: A total of 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 rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, 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.

KW - distal pancreatectomy

KW - intraperitoneal drain

KW - multicenter

KW - randomized controlled trial

UR - https://www.scopus.com/pages/publications/85022207000

U2 - 10.1097/SLA.0000000000002375

DO - 10.1097/SLA.0000000000002375

M3 - Article

C2 - 28692468

AN - SCOPUS:85022207000

SN - 0003-4932

VL - 266

SP - 421

EP - 431

JO - Annals of Surgery

JF - Annals of Surgery

IS - 3

ER -

A Prospective Randomized Multicenter Trial of Distal Pancreatectomy with and Without Routine Intraperitoneal Drainage

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Keywords

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