Biomarkers in Phototherapy of Barrett's Esophagus (BIOBAR)

This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's Esophagus, High Grade Dysplasia, Photodynamic Therapy Read More

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.