Cryotechnology for Pancreatic Necrosis
(NECTAR Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants temporarily stop using dual antiplatelet therapy or therapeutic anticoagulation if they are taking these medications.
What data supports the effectiveness of the Cryotechnology Necrosectomy Procedure treatment for pancreatic necrosis?
How is the Cryotechnology Necrosectomy Procedure treatment different from other treatments for pancreatic necrosis?
The Cryotechnology Necrosectomy Procedure is unique because it uses extremely low temperatures to treat pancreatic necrosis, which can lead to the formation of fibrous tissue without causing irreversible damage. This approach is different from traditional methods as it involves freezing the affected tissue, which is then naturally replaced by the body, potentially offering a less invasive alternative to surgery.34678
What is the purpose of this trial?
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 remove necrotic tissue from the pancreas.For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
Research Team
Christopher Thompson, MD
Principal Investigator
Brigham and Womens Hospital
Eligibility Criteria
This trial is for individuals with severe pancreatitis leading to dead pancreatic tissue, a condition known as necrosis. Participants should be candidates for an endoscopic procedure to remove this tissue. There's no specific mention of exclusion criteria in the provided information, so general health status and other factors will likely be assessed on a case-by-case basis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo direct endoscopic necrosectomy using cryoprobes to remove necrotic pancreatic tissue
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and technical success
Reintervention (if needed)
Additional interventions may be required to achieve treatment success
Treatment Details
Interventions
- Cryotechnology Necrosectomy Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Christopher C. Thompson, MD, MSc
Lead Sponsor
Erbe Elektromedizin GmbH
Industry Sponsor