Dysplastic Barrett's Esophagus, Radiofrequency Ablation, Barrett Esophagus
Conditions
Brief summary
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_TESTRadiofrequency 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 catheters treat a 1.3x2 cm (Halo 90) or 1.0x1.5 cm (Halo 60) area.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in distensibility index (DI) | Every 12 weeks, up to 1 year (4 visits) | Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure. |
| Changes in diameter | Every 12 weeks, up to 1 year (4 visits) | Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mucosal impedance | Every 12 weeks, up to 1 year (4 visits) | Damage to the mucosal lining of the esophagus and measurement of esophageal leakiness will be assessed by sensors used during RFA procedure. |
Countries
United States
Contacts
CONTACTMariah J Robran
CONTACTMichele L Johnson
PRINCIPAL_INVESTIGATORChamil C Codipilly, M.D.
Mayo Clinic
Outcome results
None listed