Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
Patients undergoing ablative therapy for management of dysplastic Barrett's Esophagus (BE) will have decreased distensibility over the course of treatment, but improvement in mucosal impedance as BE epithelia is replaced by neosquamous epithelia. This information may lead to further research in predicting therapeutic response and complications. The purpose of this research is to collect information while measuring changes related to the esophagus in patients that receive radiofrequency ablation (RFA) for dysplastic Barrett's Esophagus (BE) or esophageal cancer. Study participation includes measurements of the esophagus with the use of two different devices. This takes place during clinically indicated upper endoscopies during the timeframe the participant is receiving RFA treatments. This process will take up to an additional 10 minutes during the upper endoscopy and be done while the participant is sedated.
Eligibility criteria
Qualifiers
Male or female ≥ 18 years of age
Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)
Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)
Willing to undergo multiple rounds of endoscopic eradication therapy (EET) for management of BE (which is the guideline clinical recommendation for management of this disease)
Disqualifiers
History of esophageal ablation
History of esophageal stricture
History of esophageal or gastric surgery
Pregnancy
Trial design
Treatments tested in this trial
- Radiofrequency ablation alone
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov