This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
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.
Orlando Health
Orlando, Florida, United States
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)
Time frame: 6 months
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)
Time frame: 6 months
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
Time frame: 72 hours
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
Time frame: 72 hours
Total number of readmissions due to disease-related symptoms or procedure-related events
Assessment of readmissions due to disease-related or procedure-related events
Time frame: 6 months
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
Time frame: 24 hours
Rate of technical success for endoscopic necrosectomy
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Technical success for endoscopic necrosectomy is defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events
Time frame: 24 hours
Rate of exocrine pancreatic insufficiency
Exocrine pancreatic insufficiency is defined as fecal elastase level \< 200μg/g in patients not previously taking pancreatic enzyme supplements
Time frame: 6 months
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%
Time frame: 6 months
Rate of procedure-related adverse events
Procedure-related adverse events is defined as any adverse event occurring as a result of any endoscopic intervention
Time frame: 6 months
Rate of disease-related adverse events
Disease-related adverse events is defined as any adverse event occurring as a result of necrotizing pancreatitis
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months