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

Pancreatitis,Acute Necrotizing Clinical Trial

— DESTIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05043415
• Other study ID #: 21.067.05
• Secondary ID: 1746067
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Pancreatitis,Acute Necrotizing

Intervention

Procedure:
• Immediate endoscopic necrosectomy
In the immediate endoscopic necrosectomy group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent, immediately followed by endoscopic necrosectomy. Endoscopic necrosectomy involves removal of infected necrotic pancreatic tissue via the cystogastrostomy/cystoenterostomy tract using a variety of endoscopic accessories.
• Step-up endoscopic interventions
In the step-up endoscopic interventions group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Endoscopic necrosectomy is not performed during the index drainage session, but is performed at a later time as needed.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (8)

Lead Sponsor	Collaborator
Orlando Health, Inc.	Asian Institute of Gastroenterology, India, Marshall University, Mayo Clinic, Rush University, University of Alabama at Birmingham, University of Southern California, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of reinterventions required for treatment success	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)	6 months
Secondary	Rate of treatment success	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)	6 months
Secondary	Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)	Assessment of presence or absence of systemic inflammatory response syndrome prior to and 72 hours post intervention	72 hours
Secondary	Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention	Assessment of presence or absence of organ failure prior to and post intervention	72 hours
Secondary	Total number of readmissions due to disease-related symptoms or procedure-related events	Assessment of readmissions due to disease-related or procedure-related events	6 months
Secondary	Rate of technical success for EUS-guided cystogastrostomy	Technical success for EUS-guided cystogastrostomy is defined as the successful placement of the cystogastrostomy stent within the necrotic collection	24 hours
Secondary	Rate of technical success for endoscopic necrosectomy	Technical success for endoscopic necrosectomy is defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events	24 hours
Secondary	Rate of exocrine pancreatic insufficiency	Exocrine pancreatic insufficiency is defined as fecal elastase level < 200µg/g in patients not previously taking pancreatic enzyme supplements	6 months
Secondary	Rate of new onset diabetes	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%	6 months
Secondary	Rate of procedure-related adverse events	Procedure-related adverse events is defined as any adverse event occurring as a result of any endoscopic intervention	6 months
Secondary	Rate of disease-related adverse events	Disease-related adverse events is defined as any adverse event occurring as a result of necrotizing pancreatitis	6 months
Secondary	Post-procedure length of intensive care unit (ICU) stay	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	6 months
Secondary	Total length of hospital stay	Total length of hospital stay is defined as the number of days of patient's admission in the hospital following index intervention	6 months
Secondary	Overall treatment costs measured in US dollars	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.	6 months