Randomized Trial of Immediate Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions in Necrotizing Pancreatitis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    70
  • sponsor
    Orlando Health, Inc.
Updated on 19 September 2021

Summary

This is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

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.

Details
Condition Necrotizing pancreatitis
Treatment Immediate endoscopic necrosectomy, Step-up endoscopic interventions
Clinical Study IdentifierNCT05043415
SponsorOrlando Health, Inc.
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or over
Symptomatic 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 number of loculations, located within the pancreatic/peri-pancreatic space
Necrotic collection visualized on EUS and amenable to EUS-guided drainage

Exclusion Criteria

Age < 18 years
Females who are pregnant
Necrotic collection that is not amenable for EUS-guided drainage
Irreversible coagulopathy (defined as INR >1.5, thrombocytopenia with platelet count < 50,000/mL)
Use of anticoagulants that cannot be discontinued for the procedure
Unable to obtain consent for the procedure from either the patient or LAR
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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