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

April 21, 2026 updated by: Abel Joseph, Stanford University

Surgical vs Endoscopic Resection Of Walled Off Pancreatic Necrosis Using The Powered Endoscopic Debridement (PED) System - The SERPENT Trial

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 18 years of age or greater.
  • Patients with first episode of symptomatic WON+ due to acute pancreatitis (+Persistent fatigue, malaise, abdominal pain, gastric outlet obstruction, early satiety, fever, chills, jaundice, reduced appetite, persistent nausea/vomiting, steatorrhea)
  • Patients who are candidates for surgical or endoscopic necrosectomy of WON as deemed by a multidisciplinary committee of HPB surgeons and therapeutic endoscopists.
  • Patients who can tolerate repeat 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.

Exclusion Criteria:

  • Documented untreated pseudoaneurysm within WON.
  • Subject unable or unwilling to provide informed consent.
  • Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using pre-procedural imaging).
  • Coagulation disorders or anti-coagulant therapy which cannot be discontinued for the intervention to an absolute cardiac or vascular indication such as ACS, Stroke, Mechanical cardiovascular valves.
  • 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.
  • Non-communicating pancreatic or extra-pancreatic fluid collections.
  • Extensive abdominal surgical history due to peritoneal adhesions, prior open or recent operation during pancreatitis course, or remote gastric surgery that precludes a transgastric surgical cystgastrostomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct Endoscopic Necrosectomy
Subjects randomized to the endoscopy arm will undergo direct endoscopic necrosectomy using the Powered Endoscopic Debridement System which has CE-Mark 613797 and FDA De Novo clearance in the United States (DEN200016).
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.
Experimental: Transgastric Surgical Necrosectomy
Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric surgical necrosectomy (SN). 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Success at 6 weeks after Debridement
Time Frame: From initial intervention to 6 weeks

Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions.

AND Radiographic resolution defined as >70% reduction in WON on CT or MR imaging.
From initial intervention to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall treatment success rate at end of 6-month follow-up from date of intervention
Time Frame: From initial intervention to the end of followup at 6 months

Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions after completion of 6-month follow-up.

AND Radiographic resolution defined as >70% reduction in WON on CT or MR imaging after completion of 6-month follow-up.
From initial intervention to the end of followup at 6 months
Clinical improvement within 72 hours of debridement
Time Frame: From initial intervention to 72 hours after treatment

Clinical improvement is defined according to the criteria used in the PANTER and TENSION trial. (8-10) "Clinical improvement" defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator's medical judgement within 72 hours of the procedure, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours of the procedure.

Deterioration of these parameters by other infectious causes (e.g.urinary tract infection) will be excluded.
From initial intervention to 72 hours after treatment
Clinical Failure at 6 months
Time Frame: From initial intervention to the end of followup at 6 months
Absence of clinical improvement or clinical deterioration
From initial intervention to the end of followup at 6 months
30-day mortality
Time Frame: From initial intervention to followup at 30 days
Mortality occurring at 30 days after intervention
From initial intervention to followup at 30 days
Overall total cost of care
Time Frame: From initial intervention to the end of followup at 6 months
Cost of care per patient to achieve overall treatment success
From initial intervention to the end of followup at 6 months
Overall cost of care at 6 weeks
Time Frame: From initial intervention to followup at 6 weeks
Cost of care per patient to achieve overall primary outcome
From initial intervention to followup at 6 weeks
Percent reduction in WON collection volume (cm3) at 6-month follow-up
Time Frame: From initial intervention to the end of followup at 6 months
Percent reduction in overall size of the WON collection volume (cm3) compared to pre-treatment CT or MR imaging.
From initial intervention to the end of followup at 6 months
Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up
Time Frame: From initial intervention to the end of followup at 6 months
Percent reduction in solid necrosis component of the WON collection volume (cm3) compared to pre-treatment MRI scan.
From initial intervention to the end of followup at 6 months
Post-procedural length of hospitalization (recovery time)
Time Frame: From index intervention to hospital discharge at 6 weeks
Length of hospitalization from index intervention to hospital discharge
From index intervention to hospital discharge at 6 weeks
Readmissions
Time Frame: From initial intervention to the end of followup at 6 months
Number of hospital readmissions due to disease or procedure-related symptoms or events.
From initial intervention to the end of followup at 6 months
Reintervention rates
Time Frame: From initial intervention to the end of followup at 6 months
Need for endoscopic, radiological, or surgical intervention for additional drainage or necrotic debridement after the index intervention, excluding the follow-up procedure at 4-weeks for LAMS removal
From initial intervention to the end of followup at 6 months
Requirement of percutaneous drain
Time Frame: From initial intervention to the end of followup at 6 months
Need for additional drainage with percutaneous drain
From initial intervention to the end of followup at 6 months
Total anesthesia duration
Time Frame: On day of intervention (1 day)
Total duration of anesthesia of primary intervention
On day of intervention (1 day)
Procedure-related adverse events
Time Frame: From initial intervention to the end of followup at 6 months
Any adverse event resulting from endoscopic intervention (yes/no)
From initial intervention to the end of followup at 6 months
Disease-related adverse events
Time Frame: From initial intervention to the end of followup at 6 months
Any adverse event resulting from necrotizing pancreatitis
From initial intervention to the end of followup at 6 months
Patient satisfaction
Time Frame: From initial intervention to the end of followup at 6 months
Patient satisfaction of primary intervention at 6 weeks post intervention graded on a visual analog scale (0-10)
From initial intervention to the end of followup at 6 months
Subject quality of life (QOL)
Time Frame: From initial intervention to the end of followup at 6 months
Quality of life survey to participants at 6 month follow up. Patients will be asked to place a mark on a horizontal 10 cm line indicating his/her QoL from very poor to very good. The wording will be: "How would you rate your overall quality of life?". Higher score indicates very good quality of life and lower score indicates poor quality of life. The instrument is valid and has been used in clinical trials.
From initial intervention to the end of followup at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Indiana University Health

Investigators

  • Principal Investigator: Joo Ha Hwang, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 78066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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