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

Description

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.

Conditions

Acute Pancreatitis, Necrosis; Pancreas, Acute (Infectious)

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Study Details

Study overview

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.

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

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

Condition
Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Medical Center, Birmingham, Alabama, United States, 35294

San Francisco

California Pacific Medical Center, San Francisco, California, United States, 94110

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Erasmus Medical Center,

Marco Bruno, MD PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

Study Record Dates

2024-08-30