Prospective Study To Assess The Outcomes Of Nitrous Oxide Cryoablation For Treatment Of Duodenal Adenomas In Patients With Hereditary Conditions Such As FAP, HNPCC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Esophagogastroduodenoscopy

    Procedure/Surgery

    Esophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EGD + CBAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: