Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System

Summary

Goal:

The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis.

Participant Population:

The study will involve adult patients experiencing symptomatic WON due to acute necrotizing pancreatitis.

Main Questions:

The main questions it aims to answer are:

1. Is "endoscopy" or direct endoscopic necrosectomy (DEN) with powered endoscopic debridement (PED) as effective as "surgery" or transgastric surgical necrosectomy (SN) in achieving clinical resolution of WON within six weeks after treatment?
2. What are the rates of complications, costs, hospital length of stay, procedure time, readmission, repeat procedures and overall patient satisfaction associated with DEN with PED compared to transgastric SN?

Comparison Group:

Researchers will compare the outcomes of patients receiving DEN with PED to those undergoing transgastric SN to see if there are significant differences in clinical success, rates of complications, and overall healthcare costs.

Participants Will:

1. Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN).
2. Undergo the assigned treatment procedure based on their group.
3. Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction.
4. Be monitored for adverse events or complications following the treatment

Conditions

• Pancreatic Necrosis
• Pancreatitis

Interventions

DEVICE

Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement

Patients will first undergo endoscopic ultrasound-guided cystgastrostomy using an electrocautery-enhanced lumen apposing metallic stent to gain access to the necrosum. Direct Endoscopic Necrosectomy will be performed using the EndoRotor® NecroMax 6.0 PED Catheter which has an outer diameter of 5.1 mm and is compatible with endoscopes that have a working channel of ≥6.0 mm.

PROCEDURE

Transgastric Surgical Necrosectomy

Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric SN with the aim of creating an ample size cystgastrostomy to perform a complete debridement. In either approach, the peritoneal cavity is entered to identify the stomach through which an anterior gastrotomy is made. The retrogastric necrosum is identified either using a finder needle or ultrasound and accessed through a posterior cystgastrostomy. Transgastric SN is then manually performed, and any cyst fluid fully evacuated. The anterior gastrotomy is then closed allowing any residual necrosis or pancreatic enzyme to efflux into the stomach and enter the upper GI tract. As with endoscopy, patients with retrogastric collections are observed for a sufficient period to ensure full maturation of the necrosum.

Sponsors & Collaborators

• Indiana University Health

  collaborator OTHER

• Stanford University

  lead OTHER

Principal Investigators

• Joo Ha Hwang, MD, PhD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-31

Primary Completion

2027-05-31

Completion

2027-10-31

FDA Device

Yes