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

Erasmus University

Status: Invitation-only

Conditions: Acute Pancreatitis; Necrosis; Pancreas, Acute (Infectious)

Treatments: Device: EndoRotor® System (Interscope, Inc., Northbridge, MA USA),; Procedure: Conventional endoscopic devices (according to standards of care)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04814693

CLIN-0061

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Interventional arm

Experimental group

Description:

Subjects randomized to the control device arm will undergo treatment with the EndoRotor System, which is a powered debridement tool intended for use in endoscopic procedures to resect and remove necrotic debris during direct endoscopic necrosectomy (DEN) for walled-off necrosis. The system consists of capital components including a power console, roll stand, vacuum pump, and foot control; as well as disposable components including a single-use catheter, purge kit, and suction bag. The EndoRotor System has CE-Mark 613797 and is cleared for use by the FDA in the United States.

Treatment:

Device: EndoRotor® System (Interscope, Inc., Northbridge, MA USA),

Control arm

Active Comparator group

Description:

Subjects randomized to the control device arm will undergo conventional DEN as per the standard of care. Investigators will choose conventional DEN instruments according to their preference.

Treatment:

Procedure: Conventional endoscopic devices (according to standards of care)