Comparing two methods for removing necrotic tissue in acute pancreatitis
A Prospective, Post-Market, Multicenter, Randomized Controlled Trial to Compare the Performance of the EndoRotor® System Versus Conventional Endoscopic Techniques for Direct Endoscopic Necrosectomy of Walled Off Necrosis - The RESOlVE Trial
This study is testing if a new device called the EndoRotor® can remove dead tissue better than standard methods in patients with walled-off necrosis from acute pancreatitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 12 sites (Birmingham, Alabama and 11 other locations) |
| Trial ID | NCT04814693 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the EndoRotor® System compared to conventional endoscopic techniques for necrosectomy in patients with walled-off necrosis due to acute pancreatitis. The study focuses on patients who have undergone EUS-guided drainage and are symptomatic from pancreatic necrosis. Participants will be subjected to endoscopic procedures to assess the efficacy and safety of the EndoRotor® device in removing necrotic tissue. The trial aims to determine if this new device can improve outcomes compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic pancreatic necrosis due to acute pancreatitis who have undergone EUS-guided drainage.
Not a fit: Patients with documented pseudoaneurysms or significant coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients suffering from severe necrotizing pancreatitis.
How similar studies have performed: While conventional methods have been established, the EndoRotor® System represents a novel approach that has not been widely tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage. a. Stent must be in place for a minimum of 2 days prior to the DEN procedure. * Patients who can tolerate repeat endoscopic procedures. * Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments. * ASA classification \< 5. Exclusion Criteria: * Documented pseudoaneurysm \> 1 cm within the WON. * Subject unable or unwilling to provide informed consent. * Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound). * Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed). * Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure. * Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. * Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial. * Prior necrosectomy on existing collection. * Greater than 2 pancreatic / extra-pancreatic fluid collections.
Where this trial is running
Birmingham, Alabama and 11 other locations
- University of Alabama Medical Center — Birmingham, Alabama, United States (Not_yet_recruiting)
- California Pacific Medical Center — San Francisco, California, United States (Not_yet_recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Copenhagen University Hospital — Hvidovre, Denmark (Active_not_recruiting)
- Evangelical Hospital — Düsseldorf, Germany (Recruiting)
- University of Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
- Humanitas Reserach Hospital & Humanitas University — Milano, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Not_yet_recruiting)
- Charlotte van Veldhuisen — Amsterdam, Netherlands (Not_yet_recruiting)
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
- St. Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
- Central Manchester University Hospital — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Marco Bruno, MD PhD — Erasmus Medical Center
- Study coordinator: Marco Bruno, MD PhD
- Email: m.bruno@erasmusmc.nl
- Phone: +31107035946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.