A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage

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

Research output: Contribution to journalArticle

167 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)605-612
Number of pages8
JournalAnnals of Surgery
Volume259
Issue number4
DOIs
StatePublished - 2014

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Pancreaticoduodenectomy
Multicenter Studies
Drainage
Pancreas
Clinical Trials Data Monitoring Committees
Gastroparesis
Abdominal Abscess
Pancreatic Ducts
Comorbidity
Diarrhea
Length of Stay
Quality of Life
Demography
Pathology
Safety
Mortality
Incidence

Keywords

  • Drain
  • multicenter
  • pancreaticoduodenectomy
  • randomized
  • Whipple

ASJC Scopus subject areas

  • Surgery

Cite this

Van Buren, G., Bloomston, M., Hughes, S. J., Winter, J., Behrman, S. W., Zyromski, N. J., ... Fisher, W. E. (2014). A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Annals of Surgery, 259(4), 605-612. https://doi.org/10.1097/SLA.0000000000000460

A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. / Van Buren, George; Bloomston, Mark; Hughes, Steven J.; Winter, Jordan; Behrman, Stephen W.; Zyromski, Nicholas J.; Vollmer, Charles; Velanovich, Vic; Riall, Taylor; Muscarella, Peter; Trevino, Jose; Nakeeb, Attila; Schmidt, C. Max; Behrns, Kevin; Ellison, E. Christopher; Barakat, Omar; Perry, Kyle A.; Drebin, Jeffrey; House, Michael; Abdel-Misih, Sherif; Silberfein, Eric J.; Goldin, Steven; Brown, Kimberly; Mohammed, Somala; Hodges, Sally E.; McElhany, Amy; Issazadeh, Mehdi; Jo, Eunji; Mo, Qianxing; Fisher, William E.

In: Annals of Surgery, Vol. 259, No. 4, 2014, p. 605-612.

Research output: Contribution to journalArticle

Van Buren, G, Bloomston, M, Hughes, SJ, Winter, J, Behrman, SW, Zyromski, NJ, Vollmer, C, Velanovich, V, Riall, T, Muscarella, P, Trevino, J, Nakeeb, A, Schmidt, CM, Behrns, K, Ellison, EC, Barakat, O, Perry, KA, Drebin, J, House, M, Abdel-Misih, S, Silberfein, EJ, Goldin, S, Brown, K, Mohammed, S, Hodges, SE, McElhany, A, Issazadeh, M, Jo, E, Mo, Q & Fisher, WE 2014, 'A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage', Annals of Surgery, vol. 259, no. 4, pp. 605-612. https://doi.org/10.1097/SLA.0000000000000460
Van Buren, George ; Bloomston, Mark ; Hughes, Steven J. ; Winter, Jordan ; Behrman, Stephen W. ; Zyromski, Nicholas J. ; Vollmer, Charles ; Velanovich, Vic ; Riall, Taylor ; Muscarella, Peter ; Trevino, Jose ; Nakeeb, Attila ; Schmidt, C. Max ; Behrns, Kevin ; Ellison, E. Christopher ; Barakat, Omar ; Perry, Kyle A. ; Drebin, Jeffrey ; House, Michael ; Abdel-Misih, Sherif ; Silberfein, Eric J. ; Goldin, Steven ; Brown, Kimberly ; Mohammed, Somala ; Hodges, Sally E. ; McElhany, Amy ; Issazadeh, Mehdi ; Jo, Eunji ; Mo, Qianxing ; Fisher, William E. / A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. In: Annals of Surgery. 2014 ; Vol. 259, No. 4. pp. 605-612.
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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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T1 - A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage

AU - Van Buren, George

AU - Bloomston, Mark

AU - Hughes, Steven J.

AU - Winter, Jordan

AU - Behrman, Stephen W.

AU - Zyromski, Nicholas J.

AU - Vollmer, Charles

AU - Velanovich, Vic

AU - Riall, Taylor

AU - Muscarella, Peter

AU - Trevino, Jose

AU - Nakeeb, Attila

AU - Schmidt, C. Max

AU - Behrns, Kevin

AU - Ellison, E. Christopher

AU - Barakat, Omar

AU - Perry, Kyle A.

AU - Drebin, Jeffrey

AU - House, Michael

AU - Abdel-Misih, Sherif

AU - Silberfein, Eric J.

AU - Goldin, Steven

AU - Brown, Kimberly

AU - Mohammed, Somala

AU - Hodges, Sally E.

AU - McElhany, Amy

AU - Issazadeh, Mehdi

AU - Jo, Eunji

AU - Mo, Qianxing

AU - Fisher, William E.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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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KW - multicenter

KW - pancreaticoduodenectomy

KW - randomized

KW - Whipple

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