Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Mayo Clinic10 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dysplastic Barrett's Esophagus Radiofrequency Ablation Barrett Esophagus

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 achalasia * History of delayed gastric emptying confirmed by 4-hour gastric emptying study * Receipt of glucagon-like peptide-1 agonists * Adults lacking the capacity to consent for self * Lack of English fluency

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: Every 12 weeks, up to 1 year (4 visits)

Changes in diameter

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

Time frame: Every 12 weeks, up to 1 year (4 visits)

Secondary Outcomes

Changes in mucosal impedance

Damage to the mucosal lining of the esophagus and measurement of esophageal leakiness will be assessed by sensors used during RFA procedure.

Time frame: Every 12 weeks, up to 1 year (4 visits)

Central Contacts

Mariah J Robran

CONTACT

(507)266-3595 robran.mariah@mayo.edu

Michele L Johnson

CONTACT

johnson.michele@mayo.edu

Impact of RFA on Esophageal Distensibility and Mucosal Impedance

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts