How radiofrequency ablation affects esophagus stretchiness and mucosal impedance
Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
Mayo Clinic · NCT07126535
This study will test whether radiofrequency ablation changes how stretchy the esophagus is and the mucosal impedance in adults treated for dysplastic Barrett's esophagus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07126535 on ClinicalTrials.gov |
What this trial studies
Adults with dysplastic Barrett's esophagus receiving radiofrequency ablation will have esophageal distensibility and mucosal impedance measured during their clinically indicated upper endoscopies. Two devices will be used to obtain these measurements while the patient is sedated, adding up to about ten minutes to the procedure. Measurements will be repeated across multiple RFA sessions as Barrett's epithelium is replaced by neosquamous mucosa. The observational data will be used to explore relationships between tissue changes, treatment response, and possible complications.
Who should consider this trial
Good fit: Adults (≥18) with biopsy-proven dysplastic Barrett's esophagus or intramucosal carcinoma who can take high-dose PPI therapy and are planning to undergo multiple rounds of endoscopic radiofrequency ablation are ideal candidates.
Not a fit: Patients with prior esophageal ablation, esophageal surgery or stricture, achalasia, prior esophageal radiation or chemotherapy, pregnancy, delayed gastric emptying, recent GLP-1 agonist injection, or those unable to consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict which patients will respond well to RFA and identify risks for complications earlier.
How similar studies have performed: Previous small studies have shown changes in mucosal impedance and distensibility with treatment, but combined measurement during RFA is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * History of esophageal ablation * History of esophageal stricture * History of esophageal or gastric surgery * Pregnancy * History of esophageal cancer treated with radiation or chemotherapy * History of achalasia * History of delayed gastric emptying confirmed by 4-hour gastric emptying study * Received injection of glucagon like peptide 1 agonists within a few days prior to EGD * Adults lacking the capacity to consent for self
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Chamil C Codipilly, M.D. — Mayo Clinic
- Study coordinator: Mariah J Robran
- Email: robran.mariah@mayo.edu
- Phone: (507)266-3595
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.
Conditions: Dysplastic Barrett's Esophagus, Radiofrequency Ablation, Barrett Esophagus