About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Esophagogastroduodenoscopy
Procedure/SurgeryEsophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures.
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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