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

Official title

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

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.

Interventions

• Device EndoRotor® System (Interscope, Inc., Northbridge, MA USA),
  The EndoRotor System is intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. DEN with the EndoRotor System (study device) is considered to be standard of care therapy for patients with WON and not investigational.
• Procedure Conventional endoscopic devices (according to standards of care)
  Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.

Primary outcome measures

• The number of DEN procedures required to achieve resolution of WON [Time frame: During a 6 month follow up period]

Secondary outcome measures (9)

• Adverse events [Time frame: During a 6 month follow up period]
• Conversion to surgery defined as number of subject that require surgical intervention as a result of DEN failure as assessed by the Investigator during the index procedure through the 6 month post necrosectomy follow-up visit [Time frame: During a 6 month follow up period]
• Length of hospitalization [Time frame: During a 6 month follow up period]
• Mean total cost of care per subject [Time frame: During a 6 month follow up period]
• Percent reduction in WON collection volume (cm3) [Time frame: During a 6 month follow up period]
• Procedure time [Time frame: During a 6 month follow up period]
• Debridement time [Time frame: During a 6 month follow up period]
• Subject Quality of Life [Time frame: During a 6 month follow up period]
• The number of device deficiencies, defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance including malfunction, use errors, and inadequate labelingprocedure [Time frame: During a 6 month follow up period]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• University of Alabama Medical Center — Birmingham
• California Pacific Medical Center — San Francisco
• Thomas Jefferson University Hospital — Philadelphia

Netherlands · 3 centers

• Charlotte van Veldhuisen — Amsterdam
• Amsterdam University Medical Center — Amsterdam
• St. Antonius Hospital — Nieuwegein

Germany · 2 centers

• Evangelical Hospital — Düsseldorf
• University of Frankfurt — Frankfurt

Italy · 2 centers

• Humanitas Reserach Hospital & Humanitas University — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Denmark · 1 center

• Copenhagen University Hospital — Hvidovre

United Kingdom · 1 center

• Central Manchester University Hospital — Manchester

Identifiers

NCT: NCT04814693 · CLIN-0061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗