M.D. Anderson Cancer Center
To learn how well nitrous oxide cryoballoon ablation, a procedure that uses extreme cold to destroy abnormal tissue, works in treating flat duodenal adenomas (abnormal growths in the small intestine) in people with FAP or Lynch syndrome (HNPCC).
Primary Objectives Evaluate the Efficacy of Nitrous Oxide Cryoballoon Ablation: To determine the clinical efficacy of nitrous oxide cryoballoon ablation in achieving complete eradication of duodenal adenomas in patients with Familial Adenomatous Polyposis (FAP) and Hereditary Non-Polyposis Colorectal Cancer (HNPCC). The primary endpoint will be the complete eradication of adenomas at 12 months post-procedure, confirmed by endoscopy and histology.
Eligibility Criteria * Participants aged 20-75 years. * Confirmed diagnosis of FAP or HNPCC. * Presence of flat duodenal adenomas confirmed by histology. * Ability to understand and willingness to sign an informed consent form. Exclusion Criteria * Presence of invasive duodenal cancer. * Severe comorbidities that would contraindicate endoscopic procedures. * Allergy or intolerance to components of the nitrous oxide cryoballoon system. * Previous duodenal surgery affecting the study area. * Active gastrointestinal bleeding. Pregnancy
Esophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures.
Arctuva estimate
Verify or correct the compensation shown for this listing.