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: George Van Buren 2nd, 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-Misih, Eric J Silberfein, Steven Goldin, Kimberly Brown, Somala Mohammed, Sally E Hodges, Amy McElhany, Mehdi Issazadeh, Eunji Jo, Qianxing Mo, William E Fisher
• Journal: Annals of surgery (Ann Surg) Vol. 259 Issue 4 Pg. 605-12 (Apr 2014) ISSN: 1528-1140 [Electronic] United States
• PMID: 24374513 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Drainage (methods)
• Early Termination of Clinical Trials
• Female
• Follow-Up Studies
• Humans
• Incidence
• Length of Stay
• Male
• Middle Aged
• Pancreatic Fistula (epidemiology, etiology, prevention & control)
• Pancreaticoduodenectomy (mortality)
• Postoperative Care (adverse effects, methods)
• Postoperative Complications (epidemiology, etiology, prevention & control)
• Prospective Studies
• Severity of Illness Index
• Treatment Outcome