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Necrosectomy With Cryotechnology for Accelerated Removal

RecruitingNAAges 18 Years - anyAllChristopher C. Thompson, MD, MSc
NCT06553651 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remov

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects aged 18 years and above, inclusive of both males and females. * Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage. * Imaging indicative of ≥30% necrotic material within the pancreas. * Walled-off pancreatic necrosis (WOPN) size ≥6 cm. * Subjects able to tolerate repeated endoscopic procedures. * Capacity for providing informed consent. * Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days. Exclusion Criteria: * Inability to provide informed consent. * Unwillingness to undergo repeated endoscopies. * Presence of documented Pseudoaneurysm \> 1cm within the WOPN. * Intervening gastric varices or unavoidable blood vessels within the access tract. * Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued. * Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure. * Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential. * Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
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What it tests

  • Cryotechnology Necrosectomy Procedure
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Where

1 site
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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