Barrett's Esophagus With Persistent Dysplasia or Clinical Trial
Official title:
CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
| NCT number | NCT01882478 |
| Other study ID # | 12-006030 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2013 |
| Est. completion date | June 2021 |
| Verified date | October 2021 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response | To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA | 2 years | |
| Secondary | Predictors of response | To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy | 2 years |