Cryotherapy -BEATS-RF Ablation Trial

Mayo Clinic

Status: Completed

Conditions: Barrett's Esophagus With Persistent Dysplasia or; Early Esophageal Adenocarcinoma Post Radio Frequency Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT01882478

12-006030

Details and patient eligibility

About

The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Able to provide informed consent
• Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
• Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
• Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment

Exclusion criteria

• Age younger than 18 years old
• Life expectancy less than 12 months
• Pregnancy
• Presence of esophageal varices
• Esophageal stricture precluding passage of an endoscope and suction tubing
• Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
• Esophageal cancer (T2 and above)

Trial design

15 participants in 1 patient group

failure to respond to RF ablation

Description:

patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions