Impact of RFA on Esophageal Distensibility and Mucosal Impedance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiofrequency ablation alone.
- Who it may be relevant to
- Registry conditions: Dysplastic Barrett's Esophagus, Radiofrequency Ablation, Barrett Esophagus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
Overview
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.
Interventions
- Diagnostic test Radiofrequency ablation alone
If there is no evidence of nodularity, these patients will undergo RFA. Clinical biopsies utilizing a large-capacity biopsy forceps (Radial Jaw 4, Boston Scientific, Marlborough, MA) are obtained. RFA may be delivered through several devices under the BarrX RFA System (Medtronic USA, Minnetonka, MN), including a circumferential balloon catheter (Halo 360; figure 1), or over the scope focal catheter (Halo 90 or 60). The Halo 360 treats a circumferential 4 cm segment at a time, whereas the focal c
Primary outcome measures
- Changes in distensibility index (DI) [Time frame: Every 12 weeks, up to 1 year (4 visits)]
- Changes in diameter [Time frame: Every 12 weeks, up to 1 year (4 visits)]
Secondary outcome measures (1)
- Changes in mucosal impedance [Time frame: Every 12 weeks, up to 1 year (4 visits)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07126535 · 25-004350