A Randomized Prospective Multicenter Trial of Pancreaticoduodenectomy With and Without Routine Intraperitoneal Drainage

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

Disclosures

Annals of Surgery. 2014;259(4):605-612. 

In This Article

Abstract and Introduction

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.

Introduction

Advances in operative technique and perioperative management have reduced the mortality for pancreaticoduodenectomy (PD) to 3%. However, the morbidity of the procedure remains high and pancreatic fistula continues to be a common complication.[1] An unrecognized, and untreated, pancreatic fistula can lead to increased morbidity and mortality after PD. Routine placement of intraperitoneal drains after PD has traditionally been considered mandatory. The rationale behind placement of these drains is to evacuate blood, bile, pancreatic juice, or chyle that may accumulate after surgery and to serve as an early warning sign of anastomotic leak and associated hemorrhage. Pancreatic fistula is thought to contribute to the most morbid complications of the operation such as erosion of retroperitoneal vessels and hemorrhage, intra-abdominal abscess, sepsis, multisystem organ failure, and death.

Although the use of drains has proven to be unnecessary or even deleterious in other operations such as splenectomy, hepatectomy, gastrectomy, and colorectal resection, many surgeons fear that abandoning routine intraperitoneal drainage after PD may not be safe.[2] However, the majority of patients do not develop a postoperative pancreatic fistula; furthermore, the experience with drains in other operations suggests that drains may do more harm than good. Common concerns, which may be unfounded, are that drains can serve as portal of entry for bacteria; this may change a benign postoperative fluid collection into an abscess. Concerns also exist that drains may cause trauma from suction and can potentially erode into anastomoses and cause a fistula. Because most patients do not develop a pancreatic fistula, routine intraperitoneal drainage may subject many patients to the potential drain-related morbidities with potentially no benefit. With significant improvements in abdominal imaging and image-guided drain placement, a growing number of pancreatic surgeons have abandoned the routine use of drains arguing that a drain can be placed postoperatively in the minority of patients who require drainage.

The safety of this approach has been suggested recently in retrospective cohort studies and 1 single-institution randomized controlled trial.[3–9] The objective of this multicenter randomized prospective trial was to test the hypothesis that PD without the use of routine intraperitoneal drainage does not increase the frequency or severity of complications.

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