Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)

Mayo Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

High Grade Dysplasia

Barrett's Esophagus

Treatments

Procedure: radiofrequency ablation of barrett's esophagus

Procedure: Photodynamic therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00587600

CA97048-05

2138-00

Details and patient eligibility

About

This study is being done to find out if Photodynamic Therapy (treatment with a red light and a drug called photofrin) or Radiofrequency ablation works the same for patients who have biomarkers (abnormalities in molecules of cells that may or may not help predict cancer) present in their Barrett's esophagus as for patients who do not have biomarkers.

Enrollment

208 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients will have biopsy proven Barrett's esophagus with evidence of specialized intestinal epithelium and dysplasia (either high grade dysplasia or low grade dysplasia) on histology.
Patients must have endoscopically visible segments of Barrett's esophagus of greater than 1 centimeter in length.
All patients must be eligible for longterm follow-up as well as tolerate endoscopy, biopsy, and cytology.
Patients must be willing to travel to Rochester, Minnesota for follow-up
Patients must have a friend or relative accompany them on visits since sedatives will render them unable to operate a motor vehicle
If patients are on anticoagulation, they must be able to tolerate reversal of anticoagulation for study biopsies and therapy
All patients must be able to tolerate proton pump inhibitor therapy. Esomeprazole will be provided but can be changed to another proton pump inhibitor if the patient is intolerant.
All patients who have histological or cytological evidence of high grade dysplasia will be seen by an experienced thoracic surgeon for consideration of esophagectomy.

Exclusion criteria

Patients who are unable to follow light avoidance instructions
Patients with a history of prior esophageal surgery or successful fundoplication
Patients who had prior photodynamic therapy
Patients with pre-existing strictures in their esophagus
Patients who have known allergies to porphyrin compounds
Patients with a prior biopsies of Barrett's esophagus that contain carcinoma
Patients who require continuous anti-coagulation
Patients who are pregnant or are capable of pregnancy will be excluded from this study unless they have been on effective birth control measures
Lactating mothers are excluded from this study as it is unclear whether the photosensitizer sodium porfimer can cross to the feeding infant
Patients with underlying liver disease are excluded since their metabolism of porphyrin based photosensitizers is uncertain. Evidence of liver disease will be an transaminase elevation of three times normal, a bilirubin increase of twice normal, or an alkaline phosphatase (liver fraction) elevation of twice normal.
Patients who have underlying medical conditions that are felt to limit their survival to less than one year.