Safety and Efficacy of Video-Assisted Retroperitoneal Debridement for Infected Pancreatic Collections A Multicenter, Prospective, Single-Arm Phase 2 Study

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. Design: Multicenter, prospective, single-arm phase 2 study. Setting: Six academic medical centers. Patients: We evaluated 40 patients with pancreatic necrosis who had infection determined using Gram stain or culture. Interventions: 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. Main Outcome Measures: 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.