Comparing immediate necrosectomy to a step-up approach for treating walled-off necrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
  Hyōgo, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.