RecruitingNot Applicable

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

Japan70 participantsStarted 2022-07-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to clinical success from randomization

Timeframe: Six months

Trial details

NCT IDNCT05451901

SponsorTokyo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

Contact for this trial

Yousuke Nakai

+81-3-3815-5411 ynakai-tky@umin.ac.jp