Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

NAUnknownINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

August 18, 2021

Primary Completion Date

June 30, 2023

Study Completion Date

December 31, 2023

Conditions
Pancreatitis,Acute Necrotizing
Interventions
PROCEDURE

Immediate endoscopic necrosectomy

In the immediate endoscopic necrosectomy group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent, immediately followed by endoscopic necrosectomy. Endoscopic necrosectomy involves removal of infected necrotic pancreatic tissue via the cystogastrostomy/cystoenterostomy tract using a variety of endoscopic accessories.

PROCEDURE

Step-up endoscopic interventions

In the step-up endoscopic interventions group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Endoscopic necrosectomy is not performed during the index drainage session, but is performed at a later time as needed.

Trial Locations (1)

32806

Orlando Health, Orlando

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asian Institute of Gastroenterology, India

OTHER

collaborator

West Virginia University

OTHER

collaborator

University of Southern California

OTHER

collaborator

Marshall University

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

Rush University

OTHER

lead

Orlando Health, Inc.

OTHER

NCT05043415 - Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis | Biotech Hunter | Biotech Hunter