The Effect of Ablation Therapy on Barrett's Esophagus (ablation IN BE)

Mayo Clinic

Status: Invitation-only

Conditions: Early Esophageal Adenocarcinoma; Barrett's Esophagus

Treatments: Other: Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT00587314

258-04

Details and patient eligibility

About

To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Full description

To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma
• Ability to provide informed consent

Exclusion criteria

• Eastern Cooperative Oncology Group performance status 3 or 4
• Inability to tolerate endoscopic procedures
• Pregnancy: Females of child-bearing age will be screened with pregnancy test.

Trial design

600 participants in 1 patient group

1

Description:

Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study

Treatment:

Other: Biopsy