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Completed

NCT Number: NCT05530772

Immediate vs. On-demand Endoscopic Necrosectomy 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,

Tehran, Tehran Province, 1411713135, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic necrosectomy

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Number of necrosectomy sessions

    Time frame: Three months

    Comparing number of necrosectomy sessions between the two groups

  4. 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.

  5. Rate of new onset diabetes mellitus

    Time frame: Three months

    Comparing rate of new onset diabetes mellitus between the two groups

  6. Mortality rate

    Time frame: Three months

    Comparing mortality rate between the two groups

  7. Number of patients requiring surgery

    Time frame: Three months

    Comparing number of patients requiring surgery between the two groups

Sponsors and collaborators

Lead sponsor

University of Tehran

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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