Comparing immediate necrosectomy to a step-up approach for treating walled-off necrosis
Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
This study is testing whether a quick procedure to remove walled-off necrosis can help people with symptoms from acute pancreatitis recover faster than the usual step-by-step treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tokyo University Academic / other |
| Locations | 21 sites (Bunkyō-Ku, Tokyo and 20 other locations) |
| Trial ID | NCT05451901 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of immediate endoscopic necrosectomy (EN) following endoscopic ultrasonography (EUS)-guided drainage versus a step-up approach for managing symptomatic walled-off necrosis (WON) resulting from acute pancreatitis. The study aims to determine if immediate EN can reduce treatment duration without increasing adverse events compared to the traditional step-up method. Patients with WON that is 4 cm or larger and showing signs of infection or gastrointestinal symptoms will be enrolled. The trial will assess the time to clinical success between the two treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic walled-off necrosis that is 4 cm or larger.
Not a fit: Patients with walled-off necrosis that cannot be accessed via EUS-guided drainage or those with severe coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved outcomes for patients with infected walled-off necrosis.
How similar studies have performed: Recent evidence suggests that immediate endoscopic necrosectomy may be a safe and effective approach, indicating potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)" * Patients who cannot tolerate endoscopic procedures * Pregnant women * Patients considered inappropriate for inclusion by investigators
Where this trial is running
Bunkyō-Ku, Tokyo and 20 other locations
- Department of Gastroenterology, The University of Tokyo Hospital — Bunkyō-Ku, Tokyo, Japan (Not_yet_recruiting)
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University — Bunkyō-Ku, Tokyo, Japan (Recruiting)
- Department of Gastroenterology, Aichi Medical University — Aichi, Japan (Recruiting)
- Department of Gastroenterology, Graduate School of Medicine, Chiba University — Chiba, Japan (Recruiting)
- Department of Gastroenterology, Gifu Municipal Hospital — Gifu, Japan (Recruiting)
- Department of Gastroenterology, Gifu Prefectural General Medical Center — Gifu, Japan (Recruiting)
- First Department of Internal Medicine, Gifu University Hospital — Gifu, Japan (Not_yet_recruiting)
- Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University — Hyōgo, Japan (Recruiting)
- Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University — Kagawa, Japan (Recruiting)
- Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences — Kagoshima, Japan (Recruiting)
- Department of Gastroenterology, Kameda Medical Center — Kamogawa, Japan (Recruiting)
- Department of Gastroenterological Endoscopy, Kanazawa Medical University — Kanazawa, Japan (Not_yet_recruiting)
- Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University — Kawagoe, Japan (Not_yet_recruiting)
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital — Kawasaki, Japan (Not_yet_recruiting)
- Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine — Kobe, Japan (Recruiting)
- Department of Gastroenterology, Yuuai Medical Center — Okinawa, Japan (Recruiting)
- 2nd Department of Internal Medicine, Osaka Medical College — Osaka, Japan (Not_yet_recruiting)
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine — Ōsaka-sayama, Japan (Not_yet_recruiting)
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital — Sapporo, Japan (Recruiting)
- Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine — Tokyo, Japan (Not_yet_recruiting)
- Third Department of Internal Medicine, University of Toyama — Toyama, Japan (Recruiting)
Study contacts
- Principal investigator: Yousuke Nakai — Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
- Study coordinator: Yousuke Nakai
- Email: ynakai-tky@umin.ac.jp
- Phone: +81-3-3815-5411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.