Biomarkers in Phototherapy of Barrett's Esophagus
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 11/24/2017 |
Start Date: | December 2002 |
End Date: | April 21, 2017 |
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.
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.
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.
We found this trial at
1
site
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
Click here to add this to my saved trials