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

Last updated: October 26, 2022
Sponsor: Tokyo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Pancreatic Disorders

Treatment

N/A

Clinical Study ID

NCT05451901
2021005P
jRCT1032220055
  • Ages > 18
  • All Genders

Study 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

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

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 internationalnormalized ratio (PT-INR) >1.5
  • Patients on antithrombotic agents which cannot be managed according to the "guidelinefor gastroenterological endoscopy in patients undergoing antithrombotic treatment (DigEndosc. 2014 Jan;26(1):1-14.)"
  • Patients who cannot tolerate endoscopic procedures
  • Pregnant women
  • Patients considered inappropriate for inclusion by investigators

Study Design

Total Participants: 70
Study Start date:
July 29, 2022
Estimated Completion Date:
April 11, 2031

Study Description

Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.

Connect with a study center

  • Department of Gastroenterology, Graduate School of Medicine, Juntendo University

    Bunkyō-Ku, Tokyo
    Japan

    Active - Recruiting

  • Department of Gastroenterology, The University of Tokyo Hospital

    Bunkyō-Ku, Tokyo 113-8655
    Japan

    Site Not Available

  • Department of Gastroenterology, Aichi Medical University

    Aichi,
    Japan

    Active - Recruiting

  • Department of Gastroenterology, Graduate School of Medicine, Chiba University

    Chiba,
    Japan

    Active - Recruiting

  • Department of Gastroenterology, Gifu Municipal Hospital

    Gifu,
    Japan

    Active - Recruiting

  • Department of Gastroenterology, Gifu Prefectural General Medical Center

    Gifu,
    Japan

    Active - Recruiting

  • First Department of Internal Medicine, Gifu University Hospital

    Gifu,
    Japan

    Site Not Available

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

    Hyōgo,
    Japan

    Active - Recruiting

  • Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University

    Kagawa,
    Japan

    Active - Recruiting

  • Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences

    Kagoshima,
    Japan

    Active - Recruiting

  • Department of Gastroenterology, Kameda Medical Center

    Kamogawa,
    Japan

    Active - Recruiting

  • Department of Gastroenterological Endoscopy, Kanazawa Medical University

    Kanazawa,
    Japan

    Site Not Available

  • Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University

    Kawagoe,
    Japan

    Site Not Available

  • Department of Gastroenterology, Teikyo University Mizonokuchi Hospital

    Kawasaki,
    Japan

    Site Not Available

  • Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

    Kobe,
    Japan

    Active - Recruiting

  • Department of Gastroenterology, Yuuai Medical Center

    Okinawa,
    Japan

    Active - Recruiting

  • 2nd Department of Internal Medicine, Osaka Medical College

    Osaka,
    Japan

    Site Not Available

  • Department of Gastroenterology and Hepatology, Hokkaido University Hospital

    Sapporo,
    Japan

    Active - Recruiting

  • Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine

    Tokyo,
    Japan

    Site Not Available

  • Third Department of Internal Medicine, University of Toyama

    Toyama,
    Japan

    Active - Recruiting

  • Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine

    Ōsaka-sayama,
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.