Cryotechnology for removing necrotic pancreatic tissue
Necrosectomy With Cryotechnology for Accelerated Removal
This study is testing a new freezing technique to see if it can help doctors remove dead tissue from the pancreas more effectively in patients with severe pancreatitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06553651 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of cryotechnology in conjunction with direct endoscopic necrosectomy (DEN) to enhance the removal of necrotic pancreatic tissue in patients suffering from pancreatic necrosis due to acute pancreatitis. The procedure aims to improve the effectiveness of current endoscopic methods, which often struggle with sticky necrotic tissue. Participants will undergo repeated endoscopic procedures to assess the efficacy and safety of this innovative approach. The study is designed to provide insights into better management strategies for a condition that carries significant morbidity and mortality.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic pancreatic necrosis resulting from acute pancreatitis and significant necrotic material as indicated by imaging.
Not a fit: Patients who are unable to provide informed consent or have contraindications such as significant vascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment options for patients with pancreatic necrosis.
How similar studies have performed: While the use of cryotechnology in this context is relatively novel, similar endoscopic approaches have shown promise in managing pancreatic necrosis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christopher C. Thompson, MD, MSc — Brigham and Womens Hospital
- Study coordinator: Michele Ryan, MS
- Email: mryan@bwh.harvard.edu
- Phone: 617-525-8266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.