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

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT00587314

Collaborator

(none)

400

Enrollment

Location

228

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus Early Esophageal Adenocarcinoma	Other: Biopsy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effect of Ablation Therapy on Barrett's Esophagus

Study Start Date :

Jan 1, 2004

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
1 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	Other: Biopsy Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus

Arm

Intervention/Treatment

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

Other: Biopsy

Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus

Outcome Measures

Primary Outcome Measures

Response to treatment [at time of surveillance intervals]
presence of persistent or recurrence of barrett's esophagus and/or dysplasia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kenneth K Wang, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Kenneth K. Wang, MD, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00587314

Other Study ID Numbers:

258-04

First Posted:

Jan 7, 2008

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Keywords provided by Kenneth K. Wang, MD, Mayo Clinic

Photodynamic Therapy

Barrett's Esophagus

Early Esophageal Adenocarcinoma

Additional relevant MeSH terms:

Adenocarcinoma

Barrett Esophagus

Study Results

No Results Posted as of Mar 23, 2022