Clinical trial NCT05043415: Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
Official title: Randomized Trial Comparing Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatitis,Acute Necrotizing
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
Collaborators: name: Asian Institute of Gastroenterology, India
name: West Virginia University
name: University of Southern California
name: Marshall University
name: Mayo Clinic
name: University of Alabama at Birmingham
name: Rush University
First posted: 2021-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total number of reinterventions required for treatment success
timeFrame: 6 months
Secondary outcomes:
measure: Rate of treatment success
timeFrame: 6 months
measure: Rate of resolution of pre-intervention systemic inflammatory response syndrome (SIRS)
timeFrame: 72 hours
measure: Rate of resolution of at least 1 pre-intervention organ failure at 72 hours post index intervention
timeFrame: 72 hours
measure: Total number of readmissions due to disease-related symptoms or procedure-related events
timeFrame: 6 months
measure: Rate of technical success for EUS-guided cystogastrostomy
timeFrame: 24 hours
measure: Rate of technical success for endoscopic necrosectomy
timeFrame: 24 hours
measure: Rate of exocrine pancreatic insufficiency
timeFrame: 6 months
measure: Rate of new onset diabetes
timeFrame: 6 months
measure: Rate of procedure-related adverse events
timeFrame: 6 months
measure: Rate of disease-related adverse events
timeFrame: 6 months
measure: Post-procedure length of intensive care unit (ICU) stay
timeFrame: 6 months
measure: Total length of hospital stay
timeFrame: 6 months
measure: Overall treatment costs measured in US dollars
timeFrame: 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: