Prospective randomized comparison of EMR versus EMR followed by photodynamic therapy for the treatment of early barrett's cancer.
- Conditions
- Barrett's cancer1001799010017991
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Patients age >= 18 years treated for high-grade intraepithelial dysplasia and/or mucosal cancer with EMR, in whom follow-up biopsies do not show remaining severe neoplasia or malignancy
* Patients unable or unwilling to give informed consent
* Coagulopathy uncorrected at the time of endoscopy or thrombocytopenia (<50 x 10 9 / l thrombocytes)
* Patients with elevated liver enzymes (more than 2 times the upper limit normal)· * Patients with known porphyria, achalasia, connective tissue disease, esophagial atresia and prior caustic esophagitis
* Patients previously treated for dysplasia or cancer of the esophagus
* Patients previously treated with radiotherapy involving the mediastinum or surgical treatment of the esophagus
* A Barrett segment longer than 7 cm
* Pregnant or lactating women, or women of childbearing potential not taking adequate contraceptives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study will be the recurrence rate of histological<br /><br>proven severe dysplasia or cancer after EMR or EMR and PDT. </p><br>
- Secondary Outcome Measures
Name Time Method <p>·Complication rates of PDT: Complications are subdivided into procedural<br /><br>(during PDT) and post procedural complications (after ending the procedure).<br /><br>Complications are further subdivided into major and minor complications.<br /><br>·Mortality rates within 30 days of intervention.</p><br>