Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

Launched by ERASMUS MEDICAL CENTER · Mar 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for treating a serious condition called walled-off necrosis (WON), which can occur in patients with severe acute pancreatitis. The trial compares traditional endoscopic techniques to a new device called the EndoRotor® Resection System. The goal is to see which method is more effective in removing necrotic (dead) tissue from the pancreas and improving patient outcomes.

To participate, patients must have symptoms related to pancreatic necrosis and should have already undergone a procedure to drain the fluid. They must be able to tolerate repeated endoscopic procedures and provide written consent to be part of the study. Participants can expect to be randomly assigned to one of the two treatment methods and will have follow-up assessments to monitor their progress. It's important to know that certain conditions, like specific blood vessel issues or being pregnant, may exclude someone from participating in this trial.

Gender

ALL

Eligibility 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.