The Effect of Ablation Therapy on Barrett's Esophagus

• Conditions: Barrett's Esophagus; Early Esophageal Adenocarcinoma
• Interventions: Other: Biopsy

• Registration Number: NCT00587314
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Biopsy	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

Primary Outcome Measures

Name	Time	Method
Response to treatment	at time of surveillance intervals	presence of persistent or recurrence of barrett's esophagus and/or dysplasia

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States