Impact of RFA on Esophageal Distensibility and Mucosal Impedance

ConditionsDysplastic Barrett's Esophagus Radiofrequency Ablation Barrett Esophagus

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

This trial does not accept healthy volunteers

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 population

Subjects will be recruited from the Mayo Clinic Rochester Barrett's Esophagus practice. Clinic and upper endoscopy lists will be screened on a daily basis to identify patients who meet inclusion criteria. These patients will then be invited to participate in the study and screened by the study team.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Radiofrequency ablation alone
Diagnostic test
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 catheters treat a 1.3x2 cm (Halo 90) or 1.0x1.5 cm (Halo 60) area.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Changes in distensibility index (DI)

Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.

Time frame