title: Safety and efficacy of video-assisted retroperitoneal debridement for infected pancreatic collections: a multicenter, prospective, single-arm phase 2 study.
abstract: BACKGROUND
  The feasibility of video-assisted retroperitoneal debridement (VARD) for infected pancreatic walled-off necrosis is established. We provide prospective data on the safety and efficacy of VARD.
  
  
  METHODS
  Multicenter, prospective, single-arm phase 2 study.
  
  
  METHODS
  Six academic medical centers.
  
  
  METHODS
  We evaluated 40 patients with pancreatic necrosis who had infection determined using Gram stain or culture.
  
  
  METHODS
  Percutaneous drains were placed at enrollment, and computed tomographic scans were repeated at 10 days. Patients who had more than a 75% reduction in collection size were treated with drains. Other patients were treated with VARD. Crossover to open surgery was performed for technical reasons and/or according to surgeon judgment.
  
  
  METHODS
  Efficacy (ie, successful VARD treatment without crossover to open surgery or death) and safety (based on mortality and complication rates). Patients received follow-up care for 6 months.
  
  
  RESULTS
  We enrolled 40 patients (24 men and 16 women) during a 51-month period. Median age was 53 years (range, 32-82 years). Mean (SD) Acute Physiology and Chronic Health Evaluation II score at enrollment was 8.0 (5.1), and median computed tomography severity index score was 8. Of the 40 patients, 24 (60%) were treated with minimally invasive intervention (drains with or without VARD). Nine patients (23%) did not require surgery (drains only). For 31 surgical patients, VARD was possible in 60% of patients. Most patients (81%) required 1 operation. In-hospital 30-day mortality was 2.5% (intent-to-treat). Bleeding complications occurred in 7.5% of patients; enteric fistulas occurred in 17.5%.
  
  
  CONCLUSIONS
  This prospective cohort study supports the safety and efficacy of VARD for infected pancreatic walled-off necrosis. Of the patients, 85% were eligible for a minimally invasive approach. We were able to use VARD in 60% of surgical patients. The low mortality and complication rates compare favorably with open debridement. An unexpected finding was that a reduction in collection size of 75% according to the results of computed tomographic scans at 10 to 14 days predicted the success of percutaneous drainage alone.
authors.affiliation: Department of Surgery, University of Washington, 1959 NE Pacific St., Seattle, WA 98195, USA. khorvath@uw.edu
authors.forename: Karen
authors.initials: K
authors.lastname: Horvath
authors.forename: Patrick
authors.initials: P
authors.lastname: Freeny
authors.forename: Jaime
authors.initials: J
authors.lastname: Escallon
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.forename: Bryan
authors.initials: B
authors.lastname: Comstock
authors.forename: David J
authors.initials: DJ
authors.lastname: Glickerman
authors.forename: Eileen
authors.initials: E
authors.lastname: Bulger
authors.forename: Mika
authors.initials: M
authors.lastname: Sinanan
authors.forename: Lorrie
authors.initials: L
authors.lastname: Langdale
authors.forename: Orpheus
authors.initials: O
authors.lastname: Kolokythas
authors.forename: R Torrance
authors.initials: RT
authors.lastname: Andrews
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D003646:Debridement / Q000379:methods*; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D019283:Pancreatitis, Acute Necrotizing / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D020535:Video-Assisted Surgery