External drainage and antibiotics are the fundamental principles of treatment for infected pancreatic fluid collections following necrotizing pancreatitis. Without proper therapy, nearly all patients will die. Open surgical necrosectomy, or the process of removing necrotic tissue, is currently the standard of care. While highly effective, the large abdominal incision is associated with significant morbidity. Percutaneous catheter drainage is another type of external drainage with variable success rates. Although minimally invasive, the necrosectum often contains particulate debris, 10-30mm in size, which are poorly drained via the 4-10mm catheters. When percutaneous drainage fails, all patients crossover to open surgical necrosectomy. Preliminary data suggest that videoscopic-assisted retroperitoneal debridement (VARD) is a promising new method that combines the benefits of open surgical necrosectomy and percutaneous catheter drainage. Debridement occurs under direct vision through a small flank incision with videoscopic assistance. This project is a multicenter, single-arm, Phase II safety and efficacy study of patients undergoing VARD of infected pancreatic fluid collections. Patients enrolled will be limited to hemodynamically stable patients with documented infected pancreatic necrosis or pancreatic abscess as defined by the Atlanta Symposium. Patients will be strictly classified based on: CT classification, time from onset of pancreatitis to external drainage, and patient disease severity. Five major teaching hospitals will enroll 40 patients over 18 months. All patients will be followed for 6 months from the onset of pancreatitis. Safety issues will be monitored by an External Review Board. The hypothesis is: In patients with infected pancreatic fluid collections following acute pancreatitis, VARD provides a safe and efficacious procedure for draining infected pancreatic fluid collections adequately without need for crossover to open surgical necrosectomy.
The specific aims are to assess: 1) safety and efficacy of VARD of infected pancreatic fluid collections; and 2) the clinical and functional outcomes of patients treated with VARD. The long-term goal is to use data obtained from this study as the basis for a multicenter, Phase III, randomized study comparing the VARD to the current standard of care, open surgical necrosectomy.
| Horvath, Karen; Freeny, Patrick; Escallon, Jaime et al. (2010) Safety and efficacy of video-assisted retroperitoneal debridement for infected pancreatic collections: a multicenter, prospective, single-arm phase 2 study. Arch Surg 145:817-25 |
