title: A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage.
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.
authors.affiliation: *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.
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authors.initials: SW
authors.lastname: Behrman
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authors.lastname: Vollmer
authors.forename: Vic
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authors.lastname: Velanovich
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authors.lastname: Riall
authors.forename: Peter
authors.initials: P
authors.lastname: Muscarella
authors.forename: Jose
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authors.lastname: Trevino
authors.forename: Attila
authors.initials: A
authors.lastname: Nakeeb
authors.forename: C Max
authors.initials: CM
authors.lastname: Schmidt
authors.forename: Kevin
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authors.lastname: Behrns
authors.forename: E Christopher
authors.initials: EC
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authors.forename: Omar
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authors.lastname: Barakat
authors.forename: Kyle A
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authors.lastname: House
authors.forename: Sherif
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authors.lastname: Abdel-Misih
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Silberfein
authors.forename: Steven
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authors.lastname: Goldin
authors.forename: Kimberly
authors.initials: K
authors.lastname: Brown
authors.forename: Somala
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authors.forename: Sally E
authors.initials: SE
authors.lastname: Hodges
authors.forename: Amy
authors.initials: A
authors.lastname: McElhany
authors.forename: Mehdi
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authors.lastname: Issazadeh
authors.forename: Eunji
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authors.lastname: Jo
authors.forename: Qianxing
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authors.forename: William E
authors.initials: WE
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mesh_terms: D000328:Adult; D000368:Aged; D004322:Drainage / Q000379:methods*; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010185:Pancreatic Fistula / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D016577:Pancreaticoduodenectomy / Q000401:mortality; D011182:Postoperative Care / Q000009:adverse effects / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome