Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

Not Applicable

Active, not recruiting

• Conditions: Pancreatitis,Acute Necrotizing
• Interventions: Procedure: Step-up endoscopic interventions; Procedure: Immediate endoscopic necrosectomy

• Registration Number: NCT05043415
• Lead Sponsor: Orlando Health, Inc.

Brief Summary

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

Detailed Description

In patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. Endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (EUS) with subsequent placement of a stent. In addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.

However to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. The aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.

Study Timeline

• Study Start: 2021-08-18
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-14
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Age 18 years or over
2. Symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on MRI or CT abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall)
3. Necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space
4. Necrotic collection visualized on EUS and amenable to EUS-guided drainage

Exclusion Criteria

1. Age < 18 years
2. Females who are pregnant
3. Necrotic collection that is not amenable for EUS-guided drainage
4. Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
5. Use of anticoagulants that cannot be discontinued for the procedure
6. Unable to obtain consent for the procedure from either the patient or LAR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Step-up endoscopic intervention	Step-up endoscopic interventions	Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. In this group, only EUS-guided drainage of the necrotic collection will be performed, and endoscopic necrosectomy will be performed at a separate session at a later time as needed.
Immediate endoscopic necrosectomy	Immediate endoscopic necrosectomy	Endoscopic ultrasound (EUS)-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Then in this group, endoscopic necrosectomy will be performed immediately following index EUS-guided drainage of the necrotic collection, during the same session

Primary Outcome Measures

Name	Time	Method
Total number of reinterventions required for treatment success	6 months	Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)

Secondary Outcome Measures

Name	Time	Method
Rate of exocrine pancreatic insufficiency	6 months	Exocrine pancreatic insufficiency is defined as fecal elastase level \< 200μg/g in patients not previously taking pancreatic enzyme supplements
Rate of technical success for endoscopic necrosectomy	24 hours	Technical success for endoscopic necrosectomy is defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events
Rate of treatment success	6 months	Treatment success is defined as the resolution of necrotic collection on CT scan in association with clinical resolution of symptoms at 6-month follow-up (6 months from index intervention)
Total number of readmissions due to disease-related symptoms or procedure-related events	6 months	Assessment of readmissions due to disease-related or procedure-related events
Rate of technical success for EUS-guided cystogastrostomy	24 hours	Technical success for EUS-guided cystogastrostomy is defined as the successful placement of the cystogastrostomy stent within the necrotic collection
Rate of new onset diabetes	6 months	New onset diabetes is defined as new onset elevation in fasting plasma glucose ≥ 126 mg/dL, 2-hour plasma glucose ≥ 200 mg/dL after an oral glucose tolerance test or HbA1c ≥ 6.5%
Post-procedure length of intensive care unit (ICU) stay	6 months	Post-procedure length of intensive care unit (ICU) stay is defined as the number of days of patient's admission to the ICU following index intervention
Total length of hospital stay	6 months	Total length of hospital stay is defined as the number of days of patient's admission in the hospital following index intervention
Overall treatment costs measured in US dollars	6 months	Overall treatment costs include all relevant costs pertaining to treatment such as procedure costs, inpatient hospital stay costs, medication costs, materials costs, anesthesia costs, pharmacy costs and imaging studies costs.
Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)	72 hours	Assessment of presence or absence of systemic inflammatory response syndrome prior to and 72 hours post intervention
Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention	72 hours	Assessment of presence or absence of organ failure prior to and post intervention
Rate of procedure-related adverse events	6 months	Procedure-related adverse events is defined as any adverse event occurring as a result of any endoscopic intervention
Rate of disease-related adverse events	6 months	Disease-related adverse events is defined as any adverse event occurring as a result of necrotizing pancreatitis

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States