Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For pati
| Condition(s) | Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients wi |
| Who can participate | Inclusion Criteria: * Patients with WON defined according to the revised Atlanta classification * The longest diameter of WON is 4 cm or larger * Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice * Patients who need drainage for WON * Age of 18 years or older * Patients or their representatives provide informed consent * Patients who visit or are hospitalized at the participating institutions Exclusion Criteria: * WON inaccessible by EUS-guided approach * AXIOS stent has already been placed into the WON prior to the enrollment * Severe coagulopathy; Platelet count \< 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) \>1.5 * Patients on antithrombotic agents which cannot be |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tokyo University |
| Locations | Bunkyō-Ku, Tokyo, Japan; Bunkyō-Ku, Tokyo, Japan; Aichi, Japan; Chiba, Japan; Gifu, Japan; Gifu, Japan (+15 more sites) |
| Start date | 2022-07-29 |
| NCT ID | NCT05451901 |
| Official listing | https://clinicaltrials.gov/study/NCT05451901 |