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

RecruitingNAAges 18 Years - anyAllTokyo University
NCT05451901 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Immediate necrosectomy
  • Step-up approach
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Where

21 sites
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Japan
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Japan
Department of Gastroenterology, Aichi Medical University
Aichi, Japan
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba, Japan
Department of Gastroenterology, Gifu Municipal Hospital
Gifu, Japan
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu, Japan
First Department of Internal Medicine, Gifu University Hospital
Gifu, Japan
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
Hyōgo, Japan

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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