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

Stichting voor Lever en Maag-Darm Onderzoek (SLO)0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•1. Patients 18 years of age or greater.
•2. 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
•3. Patients who can tolerate repeat endoscopic procedures.
•4. 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.
•5. ASA classification < 5.

•1. Documented pseudoaneurysm > 1 cm within the WON.
•2. Subject unable or unwilling to provide informed consent.
•3. Intervening gastric varices or unavoidable blood vessels within the WON
•access tract (visible using
•endoscopy or endoscopic ultrasound).
•4. Coagulation disorders or anti-coagulant therapy which cannot be discontinued
•(aspirin allowed).
•5. 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.
•6. 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.
•7. Patient is enrolled in another trial that could interfere with the endpoint
•analyses of this trial.
•8. Prior necrosectomy on existing collection.
•9. Greater than 2 pancreatic / extra-pancreatic fluid collections.

发起方

Stichting voor Lever en Maag-Darm Onderzoek (SLO)