Clinical trial NCT04814693: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Necrosis; Pancreas, Acute (Infectious)
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Interscope, Inc.
First posted: 2021-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects in this study will be included in either the intervention arm (EndoRotor) of control arm (conventional procedures).
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: The number of DEN procedures required to achieve resolution of WON
timeFrame: During a 6 month follow up period
Secondary outcomes:
measure: Adverse events
timeFrame: During a 6 month follow up period
measure: 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
timeFrame: During a 6 month follow up period
measure: Length of hospitalization
timeFrame: During a 6 month follow up period
measure: Mean total cost of care per subject
timeFrame: During a 6 month follow up period
measure: Percent reduction in WON collection volume (cm3)
timeFrame: During a 6 month follow up period
measure: Procedure time
timeFrame: During a 6 month follow up period
measure: Debridement time
timeFrame: During a 6 month follow up period
measure: Subject Quality of Life
timeFrame: During a 6 month follow up period
measure: 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
timeFrame: During a 6 month follow up period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medical Center
state: Alabama
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital
city: Düsseldorf
country: Germany
facility: Evangelical Hospital
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Milano
country: Italy
facility: Humanitas Reserach Hospital & Humanitas University
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Amsterdam
country: Netherlands
facility: Charlotte van Veldhuisen
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Marco Bruno, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: