NCT06553651 Necrosectomy With Cryotechnology for Accelerated Removal
| NCT ID | NCT06553651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christopher C. Thompson, MD, MSc |
| Condition | Pancreatic Necrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-12 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-12 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Christopher C. Thompson, MD, MSc
PRINCIPAL INVESTIGATOR
Brigham and Womens Hospital
Frequently Asked Questions
Who can join the NCT06553651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Necrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06553651 currently recruiting?
Yes, NCT06553651 is actively recruiting participants. Contact the research team at mryan@bwh.harvard.edu for enrollment information.
Where is the NCT06553651 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06553651 clinical trial?
NCT06553651 is sponsored by Christopher C. Thompson, MD, MSc. The principal investigator is Christopher C. Thompson, MD, MSc at Brigham and Womens Hospital. The trial plans to enroll 20 participants.