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Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointestinal endoscopy Stassen, P. M., de Jonge, P. J., Bruno, M. J., Koch, A. D., Trindade, A. J., Benias, P. C., Sejpal, D. V., Siddiqui, U. D., Chapman, C. G., Villa, E., Tharian, B., Inamdar, S., Hwang, J. H., Barakat, M. T., Andalib, I., Gaidhane, M., Sarkar, A., Shahid, H., Tyberg, A., Binmoeller, K., Watson, R. R., Nett, A., Schlag, C., Abdelhafez, M., Friedrich-Rust, M., Schlachterman, A., Chiang, A. L., Loren, D., Kowalski, T., Kahaleh, M. 2021

Abstract

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and require repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN.METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN =6 cm and =22 cm, with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life.RESULTS: Thirty patients (mean age 55 years, 60% male) underwent DEN with no device-related adverse events. Fifteen out of 30 (50%) achieved complete debridement in 1 session, and 20 out of 30 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range 1-7) were required. Median hospital stay was 10 days (IQR 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated to total number of interventions (rho=0.363, p=0.049).CONCLUSION: The new PED system seems to be a safe and effective treatment tool for WOPN resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed.

View details for DOI 10.1016/j.gie.2021.09.025

View details for PubMedID 34562471