NCT05451901 Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
| NCT ID | NCT05451901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tokyo University |
| Condition | Pancreatic Fluid Collection |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-07-29 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2022-07-29 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 with symptomatic WON.
Eligibility 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
Contact & Investigator
Yousuke Nakai
PRINCIPAL INVESTIGATOR
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
Frequently Asked Questions
Who can join the NCT05451901 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Fluid Collection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05451901 currently recruiting?
Yes, NCT05451901 is actively recruiting participants. Contact the research team at ynakai-tky@umin.ac.jp for enrollment information.
Where is the NCT05451901 trial being conducted?
This trial is being conducted at Bunkyō-Ku, Japan, Bunkyō-Ku, Japan, Aichi, Japan, Chiba, Japan and 11 additional locations.
Who is sponsoring the NCT05451901 clinical trial?
NCT05451901 is sponsored by Tokyo University. The principal investigator is Yousuke Nakai at Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo. The trial plans to enroll 70 participants.