Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Japan
Department of Gastroenterology, Aichi Medical University
RECRUITING
Aichi
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
RECRUITING
Bunkyō-ku
Department of Gastroenterology, The University of Tokyo Hospital
NOT_YET_RECRUITING
Bunkyō-ku
Department of Gastroenterology, Graduate School of Medicine, Chiba University
RECRUITING
Chiba
Department of Gastroenterology, Gifu Municipal Hospital
RECRUITING
Gifu
Department of Gastroenterology, Gifu Prefectural General Medical Center
RECRUITING
Gifu
First Department of Internal Medicine, Gifu University Hospital
NOT_YET_RECRUITING
Gifu
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
RECRUITING
Hyōgo
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
RECRUITING
Kagawa
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
RECRUITING
Kagoshima
Department of Gastroenterology, Kameda Medical Center
RECRUITING
Kamogawa
Department of Gastroenterological Endoscopy, Kanazawa Medical University
NOT_YET_RECRUITING
Kanazawa
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
NOT_YET_RECRUITING
Kawagoe
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
NOT_YET_RECRUITING
Kawasaki
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
RECRUITING
Kobe
Department of Gastroenterology, Yuuai Medical Center
RECRUITING
Okinawa
2nd Department of Internal Medicine, Osaka Medical College
NOT_YET_RECRUITING
Osaka
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
NOT_YET_RECRUITING
Ōsaka-sayama
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
RECRUITING
Sapporo
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
NOT_YET_RECRUITING
Tokyo
Third Department of Internal Medicine, University of Toyama
RECRUITING
Toyama
Contact Information
Primary
Yousuke Nakai
ynakai-tky@umin.ac.jp
+81-3-3815-5411
Backup
Tomotaka Saito
tomsaito-gi@umin.ac.jp
+81-3-3815-5411
Time Frame
Start Date: 2022-07-29
Estimated Completion Date: 2031-04-11
Participants
Target number of participants: 70
Treatments
Experimental: Immediate necrosectomy
Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success.
Active_comparator: Step-up approach
Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment.
Sponsors
Leads: Tokyo University

This content was sourced from clinicaltrials.gov