An interventional study of Endoscopic necrosectomy in Pancreatitis, Acute Necrotizing, sponsored by University of Tehran. Completed at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by University of Tehran · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 42 interventional studies indexed under Pancreatitis, Acute Necrotizing.
Browse Pancreatitis, Acute Necrotizing studies →University of Tehran is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
Clinical success rate
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
Time frame: Three months
procedure-related adverse events
Comparing procedure-related adverse events between the two groups. Adverse events including bleeding, perforation, secondary infection are compared.
Time frame: Three months
Length of hospital stay
Comparing length of hospital stay between the two groups. Total length of hospital stay is recorded and compared.
Time frame: Three months
Number of necrosectomy sessions
Comparing number of necrosectomy sessions between the two groups
Time frame: Three months
Total duration of necrosectomies (in miniute)
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.
Time frame: Three months
Rate of new onset diabetes mellitus
Comparing rate of new onset diabetes mellitus between the two groups
Time frame: Three months
Mortality rate
Comparing mortality rate between the two groups
Time frame: Three months
Number of patients requiring surgery
Comparing number of patients requiring surgery between the two groups
Time frame: Three months
Plan to share: Yes — IPD will be shared with other researchers for collaborative studies upon request from the principle investigator
Supporting information: Study protocol, Csr
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Pancreatitis, Acute Necrotizing→
University of Tehran