Cryotherapy -BEATS-RF Ablation Trial

CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01882478

Enrollment

Registered

2013-06-20

Start date

2013-06-30

Completion date

2021-06-30

Last updated

2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma Post Radio Frequency Ablation

Keywords

Barrett's esophagus, Early esophageal adenocarcinoma, Radio Frequency Ablation, Cryotherapy

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results