Endoscopic Necrosectomy Versus Step-up Endoscopic Intervention

Completed · Not applicable

Conditions studied: Pancreatic Necrosis, Necrosis Pancreas

In brief

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.

Key facts

Study ID

NCT04113499

Run by

AdventHealth

People needed

11

Starts

2019-11-27

Expected to finish

2022-04-25

Last updated by the study team

2023-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Interventional Endoscopy — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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