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

Summary

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Marshall University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Rush University

  collaborator OTHER

• Orlando Health, Inc.

  lead OTHER

Principal Investigators

• Ji Young Bang, MD MPH · Orlando Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-18

Primary Completion

2023-06-30

Completion

2023-12-31

Countries

• United States

Study Locations