Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
WONDER-01
2 other identifiers
interventional
70
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2031
ExpectedOctober 27, 2022
October 1, 2022
2.7 years
July 3, 2022
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to clinical success from randomization
Clinical success is defined as 1) a decrease in the WON size to 3 cm or less and 2) an improvement of more than two out of the three following inflammatory markers; body temperature, white blood cell count, and C-reactive protein.
Six months
Secondary Outcomes (19)
Adverse events
Five years
Mortality
Five years
Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)
One day
Incidence of biliary and gastrointestinal stricture
Five years
Number and time of interventions
Six months
- +14 more secondary outcomes
Study Arms (2)
Immediate necrosectomy
EXPERIMENTALEndoscopic 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.
Step-up approach
ACTIVE COMPARATORStep-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.
Interventions
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement.
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tokyo Universitylead
Study Sites (21)
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655, Japan
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo, 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
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa, Japan
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima, Japan
Department of Gastroenterology, Kameda Medical Center
Kamogawa, Japan
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Kanazawa, Japan
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe, Japan
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki, Japan
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe, Japan
Department of Gastroenterology, Yuuai Medical Center
Okinawa, Japan
2nd Department of Internal Medicine, Osaka Medical College
Osaka, Japan
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka-sayama, Japan
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Sapporo, Japan
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo, Japan
Third Department of Internal Medicine, University of Toyama
Toyama, Japan
Related Publications (2)
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PMID: 23100216BACKGROUNDSato T, Saito T, Takenaka M, Iwashita T, Shiomi H, Fujisawa T, Hayashi N, Iwata K, Maruta A, Mukai T, Masuda A, Matsubara S, Hamada T, Inoue T, Ohyama H, Kuwatani M, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Ogura T, Nakahara K, Doi S, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan, collaborators. WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis-study protocol for a multicentre randomised controlled trial. Trials. 2023 May 24;24(1):352. doi: 10.1186/s13063-023-07377-y.
PMID: 37226252DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yousuke Nakai
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital
Study Record Dates
First Submitted
July 3, 2022
First Posted
July 11, 2022
Study Start
July 29, 2022
Primary Completion
April 1, 2025
Study Completion (Estimated)
April 11, 2031
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share