Cryotherapy -BEATS-RF Ablation Trial

Completed

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

• Registration Number: NCT01882478
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-20
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response	2 years	To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA

Secondary Outcome Measures

Name	Time	Method
Predictors of response	2 years	To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States