Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis

October 10, 2025 updated by: Mehdi Mohamadnejad, University of Tehran

Immediate Endoscopic Necrosectomy vs. On-demand Necroectomy in Infected Walled-off Pancreatic Necrosis

Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications. Approximately, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality. Initial conservative management may be feasible in necrotizing pancreatitis, however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure. Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy. Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy. The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications (1). The incidence of acute pancreatitis is trending upward in the United States with $2.6 billion annual health care costs (2). While most patients present with mild and interstitial form of pancreatitis, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality (3). Initial conservative management may be feasible in necrotizing pancreatitis (4), however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure (5). Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. Drainage procedures are typically postponed for several weeks until the necrotic cavity becomes walled off which is called walled off pancreatic necrosis (WOPN).

In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy (6). Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy (7).

The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN.

Infected necrosis is diagnosed with one of the following criteria in patients with WOPN three weeks after onset of acute pancreatitis (8): A. Positive Gram's stain or culture from a fine-needle aspiration; B. the presence of gas within pancreatic and peripancreatic necrosis on contrast-enhanced CT scan; C. Presence of two inflammatory variables (temperature >38.5°C or elevated C-reactive protein levels or leukocyte counts) in the absence of another focus of infection (other than infected necrosis) ; D. Presence of persistent organ failure.

Study Type

Interventional

Enrollment (Actual)

50

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.

Study Locations

  • Iran
    • Tehran Province
      • Tehran, Tehran Province, Iran, 1411713135
        • Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented history of acute pancreatitis
  • Necrotic collection with partial or complete wall diagnosed on CT or MRI
  • Necrotic collection of any size with any number of loculations with more than 20% of solid/necrotic component
  • Necrotic collection is accessible and amenable for EUS-guided drainage
  • Age >= 18 years
  • Suspected or confirmed infection in the necrotic collection
  • The patient understands and accepts to sign the informed consent.

Exclusion Criteria:

  • Irreversible coagulopathy with INR>1.5 or platelet counts <50,000
  • Necrotic collection is not accessible for EUS-guided drainage
  • Females who are pregnant
  • Previous intervention (e,g, percutaneous drainage, or surgery) is performed for the patient

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: On-demand endoscopic necrosectomy
The subject will have EUS-guided transmural drainage of the necrotic collection The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. In this group, endoscopic necrosectomy is not performed at the time of index procedure. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated.
Device: Endoscopic necrosectomy
Initially, a tract is created between the stomach or duodenum with the walled-off pancreatic necrotic collection through placement of a stent. Then, the endosocpe is entered the necrotic cavity with CO2 insufflation, and the necrotic materials are removed with snare, grasper, or suctioning.
Experimental: Immediate endoscopic Necrosectomy

The subject will have endoscopic necrosectomy at the time of the EUS-guided transmural stent placement.

The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. Immediately after stent placement, the cystoenterostomy track is dilated with a 15 mm through the scope (TTS) balloon. Then, direct endoscopic necrosectomy is performed with CO2 insufflation. The duration of necrosectomy will be 30 to 90 minutes. If complete clearance of the cavity is achieved before 30 minutes, the duration of necrosectomy may be less than 30 minutes in the given session. Also, if any complication occurs during necrosectomy, appropriate management will be done, and the procedure may be concluded earlier.
Device: Endoscopic necrosectomy
Initially, a tract is created between the stomach or duodenum with the walled-off pancreatic necrotic collection through placement of a stent. Then, the endosocpe is entered the necrotic cavity with CO2 insufflation, and the necrotic materials are removed with snare, grasper, or suctioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate
Time Frame: Three months
Clinical success rate is compared between the two groups. Clinical success is defined as complete resolution of WOPN without residual fluid component along with resolution of symptoms three months after stent placement
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure-related adverse events
Time Frame: Three months
Comparing procedure-related adverse events between the two groups. Adverse events including bleeding, perforation, secondary infection are compared.
Three months
Length of hospital stay
Time Frame: Three months
Comparing length of hospital stay between the two groups. Total length of hospital stay is recorded and compared.
Three months
Number of necrosectomy sessions
Time Frame: Three months
Comparing number of necrosectomy sessions between the two groups
Three months
Total duration of necrosectomies (in miniute)
Time Frame: Three months
Comparing total duration of necrosectomies (in miniute) between the two groups. Total duration of necrosectomies (in miniute) in all necroectomy sessions is recorded and compared between the two groups.
Three months
Rate of new onset diabetes mellitus
Time Frame: Three months
Comparing rate of new onset diabetes mellitus between the two groups
Three months
Mortality rate
Time Frame: Three months
Comparing mortality rate between the two groups
Three months
Number of patients requiring surgery
Time Frame: Three months
Comparing number of patients requiring surgery between the two groups
Three months

Collaborators and Investigators

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

Sponsor

University of Tehran

Investigators

  • Study Chair: Alireza Delavari, MD, Chair, Digestive dieseases research institute, Tehran University of Medical Sciences

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

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 (Actual)

September 12, 2022

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDRI.1401.008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with other researchers for collaborative studies upon request from the principle investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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