Comparing Immediate Endoscopic Necrosectomy to Step-up Approach After EUS-guided Drainage in Adults with Walled-off Necrosis

What this Trial Is About

Walled-off necrosis WON is a pancreatic fluid collection containing dead tissue that forms at least four weeks after acute pancreatitis begins. This condition can lead to serious infection and complications, requiring treatment. The trial compares two approaches for managing symptomatic WON immediate endoscopic necrosectomy EN right after endoscopic ultrasonography EUS-guided drainage, versus a step-up approach where EN is delayed and used only if needed. The study aims to see which method leads to faster clinical improvement without increasing risks. Participants will receive EUS-guided drainage within 72 hours of randomization using a specialized stent to access the WON area. In one group, EN is performed immediately during the same session to remove dead tissue directly and repeated until improvement. In the other group, patients start with drainage only if symptoms persist after 72-96 hours, additional drainage or percutaneous methods are added. EN is reserved for cases not improving after these step-up treatments. During the study, participants will be monitored for time to clinical success over six months. Researchers will evaluate the safety and effectiveness of each approach by tracking adverse events, mortality, technical success of drainage, hospital and ICU stays, antibiotic use, and recurrence of WON or other pancreatic issues over up to five years. The total duration of involvement may extend to several years to assess long-term outcomes and complications.

Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis