A randomised controlled trial to study the side effect profile and to establish measures of efficacy using photofrin or 5-aminolaevulinic acid (ALA) photodynamic therapy in the eradication of dysplasia in Barrett?s columnar lined oesophagus
Completed
- Conditions
- High grade dysplasia in Barrett's oesophagusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN16444200
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
1. Patients with high grade dysplasia in Barrett's oesophagus but without invasive cancer
2. Aged over 21
Exclusion Criteria
1. Severe cardiovascular disease
2. Liver cirrhosis or seriously impaired hepatic or renal function
3. Depot antipsychotics
4. Concomitant chemoradiotherapy
5. Pregnancy
6. Porphyria
7. Previous photodynamic therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Eradication of high grade dysplasia<br>2. Prevention of oesophageal cancer<br>3. Side effect profiles of different types of photodynamic therapy
- Secondary Outcome Measures
Name Time Method 1. Quality of life outcomes<br>2. Develop novel methods for treatment efficacy <br>3. Reversal of Barrett's oesophagus