An interventional study of Direct Endoscopic Intervention and Step-up Endoscopic Intervention in Pancreatic Necrosis and Necrosis Pancreas, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
This trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature into a contained necrotic collection, typically four weeks into the disease course. With intense conservative management, including nutritional and intensive care support when required, the collection may resolve without intervention. However, a persistent collection with pain, gastric outlet, intestinal or biliary obstruction, new-onset or persisting organ failure, persistent unwellness or infection is associated with a mortality of 15-20%, and requires necrosectomy and drainage. Without intervention, infected necrosis ultimately leads to death in nearly every patient.
Recently, there has been a shift away from surgical debridement (necrosectomy) towards minimally-invasive endoscopic methods in the treatment of necrotizing pancreatitis. Endoscopic management involves creation of a fistula between the enteric wall and necrotic collection under the guidance of endoscopic ultrasound [EUS] with subsequent placement of a stent to allow drainage of the necrotic material. Endoscopic transenteral drainage of necrotic collection is associated with favorable outcomes, with treatment success rates reported in the range of 45-70%. Endoscopic necrosectomy, with the additional technique of extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%.
However, there are currently scant data on the optimal timing of endoscopic necrosectomy. In a retrospective study, performing endoscopic necrosectomy at the time of the initial EUS-guided drainage of the necrotic collection was associated with a significantly lower number of necrosectomy sessions compared to performing endoscopic necrosectomy one week after drainage.
The aim of this randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.
70 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's enrollment of 11 is below the median of 70 across 45 interventional studies indexed under Pancreatitis, Acute Necrotizing.
Browse Pancreatitis, Acute Necrotizing studies →AdventHealth is the lead sponsor of 113 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Documented history of acute pancreatitis Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met
Exclusion Criteria:
The subject will have endoscopic drainage and necrosectomy at the time of the index intervention.
Procedure: Direct Endoscopic Intervention
The subject will only have endoscopic drainage of the pancreatic necrotic collection at the time of index intervention.
Procedure: Step-up Endoscopic Intervention
The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities. For endoscopic necrosectomy, in patients allocated to direct endoscopic necrosectomy group, endoscopic necrosectomy is performed during the same session as the index endoscopic drainage. It is performed using a therapeutic gastroscope and various accessories (see below for further details) for 90 to 120 minutes.
The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities. In patients allocated to the step-up endoscopic interventions group, endoscopic necrosectomy is not performed at the time of the index intervention, however it is performed when clinically indicated during the follow-up period (6 months from index intervention).
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
Time frame: 6 months
Rate of resolution of pre-intervention systemic inflammatory response syndrome
Assessment of preintervention systemic inflammatory response syndrome \& their resolution and measured by yes/no.
Time frame: 72 hours post index procedure
Rate of resolution of at least 1 pre-intervention organ failure
Assessment of organ failure following the index procedure and their resolution and measured by yes/no.
Time frame: 72 hours post index procedure
Number of re-admissions
Assessing the total number of re-admissions following the index procedure.
Time frame: 6 months
Rate of technical success for EUS-guided cystogastrostomy
Technical success for EUS-guided cystogastrostomy defined as completion of endoscopic necrosectomy session as planned without the occurrence of adverse events and measured by yes/no.
Time frame: 24 hours
Rate of technical success for endoscopic necrosectomy
Technical success for endoscopic necrosectomy defined as any adverse event occurring as a result of necrotizing pancreatitis and measured by yes/no.
Time frame: 6 months
Rate of exocrine pancreatic insufficiency
Rate of exocrine pancreatic insufficiency defined as fecal elastase level \< 200μg/g in patients not previously taking pancreatic enzyme supplements
Time frame: 6 months
Rate of new onset diabetes
Rate of new onset diabetes 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
Number of Procedure-related adverse events
Procedure-related adverse events defined as any adverse event occurring as a result of any endoscopic intervention. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Time frame: 6 months
Number of Disease-related adverse events
Disease-related adverse events, defined as any adverse event occurring as a result of necrotizing pancreatitis. The subject will be asked to report and medical records will be reviewed for any adverse events related to the procedure.
Time frame: 6 months
Post-procedure length of intensive care unit (ICU) stay
Measured in the number of days in the intensive care unit
Time frame: 6 months
Total length of hospital stay
Measured in the number of days in the hospital
Time frame: 6 months
Overall treatment costs
Overall treatment costs from admission until 6 months post index intervention. All relevant costs pertaining to treatment will be taken into consideration - procedure costs, inpatient hospital stay from date of procedure to discharge, readmissions, medications, materials, anesthesia, pharmacy and imaging studies.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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