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

• Conditions: encapsulated pancreatic necrosis; Walled-off pancreatic necrosis; 10017998

• Registration Number: NL-OMON52160
• Lead Sponsor: Stichting voor Lever en Maag-Darm Onderzoek (SLO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

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
procedure.
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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified