Status:
COMPLETED
Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention
Lead Sponsor:
AdventHealth
Conditions:
Pancreatic Necrosis
Necrosis Pancreas
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 infe...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements
- The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures
- Males or females ≥ 18 years of age
- Necrotic collection 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)
- Necrotic collection of any size with ≥ 33% of solid/necrotic component and any no. of loculations, located within the pancreatic/peri-pancreatic space
- Necrotic collection visualized on EUS and amenable to EUS-guided drainage
- Suspected/confirmed infected necrotic collection. Infected necrosis is defined by the presence of gas in the necrotic collection on cross-sectional imaging or positive culture of necrotic tissue obtained preprocedure or at first intervention. Infected necrosis is also suspected when sepsis is persistent or in the presence of ongoing clinical deterioration.
- Documented history of acute pancreatitis Acute pancreatitis is diagnosed if 2 of the following 3 criteria are met
- Abdominal pain characteristic of acute pancreatitis
- Serum lipase/amylase ≥ x3 upper limit of normal
- Characteristic radiological findings of acute pancreatitis on CECT/MRI/US abdomen, such as homogeneous enhancement of pancreatic parenchyma, standing of peripancreatic fat
- Able to undergo general anesthesia
Exclusion
- Females who are pregnant or lactating. Pregnancy for females of childbearing potential will be determined by routine preoperative urine or serum HCG testing.
- Irreversible coagulopathy (INR \>1.5, thrombocytopenia with platelet count \<50,000/mL)
- Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass
- Age \< 18 years
- Unable to obtain consent for the procedure from either the patient or LAR
- Use of anticoagulants that cannot be discontinued for the procedure
- Unable to tolerate general anesthesia
- Necrotic collection that is not accessible for EUS-guided drainage
- Percutaneous drainage of the necrotic collection is required or performed prior to EUS-guided drainage
Key Trial Info
Start Date :
November 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04113499
Start Date
November 27 2019
End Date
April 25 2022
Last Update
July 12 2023
Active Locations (1)
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1
Center for Interventional Endoscopy
Orlando, Florida, United States, 32803