Cryotherapy -BEATS-RF Ablation Trial
Conditions
Barrett's Esophagus With Persistent Dysplasia or - Early Esophageal Adenocarcinoma After Radio Frequency Ablation
Conditions: official terms
Adenocarcinoma - Barrett Esophagus - Esophageal Neoplasms
Conditions: Keywords
Barrett's esophagus, Early esophageal adenocarcinoma, Radio Frequency Ablation, Cryotherapy
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Location
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Lori S Lutzke - 507-255-7495 - lutzke.lori@mayo.edu
Start Date
June 2013
Completion Date
June 2020
Sponsors
Mayo Clinic
Source
Mayo Clinic
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page