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NCT05451901Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
3 Jul 2022
Start date
29 Jul 2022
Primary completion date
1 Apr 2025
Lead sponsor
Tokyo University
NCT number
NCT05451901

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 29 Jul 2022 to the primary completion date, 1 Apr 2025
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • AXIOS stent has already been placed into the WON prior to the enrollment

Lab values

  • Severe coagulopathy; Platelet count \< 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) \>1.5

Other

  • WON inaccessible by EUS-guided approach
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Gastroenterology, Aichi Medical University
Coordinator of this site? Confirm its status
AichiJapanRecruiting
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Coordinator of this site? Confirm its status
Bunkyō-KuJapanRecruiting
Department of Gastroenterology, The University of Tokyo Hospital
Coordinator of this site? Confirm its status
Bunkyō-KuJapanNot yet recruiting
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Coordinator of this site? Confirm its status
ChibaJapanRecruiting
Department of Gastroenterology, Gifu Prefectural General Medical Center
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GifuJapanRecruiting
Department of Gastroenterology, Gifu Municipal Hospital
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GifuJapanRecruiting
First Department of Internal Medicine, Gifu University Hospital
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GifuJapanNot yet recruiting
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
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HyōgoJapanRecruiting
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
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KagawaJapanRecruiting
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
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KagoshimaJapanRecruiting
Department of Gastroenterology, Kameda Medical Center
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KamogawaJapanRecruiting
Department of Gastroenterological Endoscopy, Kanazawa Medical University
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KanazawaJapanNot yet recruiting
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
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KawagoeJapanNot yet recruiting
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
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KawasakiJapanNot yet recruiting
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
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KobeJapanRecruiting
Department of Gastroenterology, Yuuai Medical Center
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OkinawaJapanRecruiting
2nd Department of Internal Medicine, Osaka Medical College
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OsakaJapanNot yet recruiting
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
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Ōsaka-sayamaJapanNot yet recruiting
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
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SapporoJapanRecruiting
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Coordinator of this site? Confirm its status
TokyoJapanNot yet recruiting
Third Department of Internal Medicine, University of Toyama
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ToyamaJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.