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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16444200
Enrollment
66
Registered
2006-02-07
Start date
2006-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High grade dysplasia in Barrett's oesophagus Nutritional, Metabolic, Endocrine High grade dysplasia in Barrett's oesophagus

Interventions

Photodynamic therapy using 5-aminolaevulinic acid versus photofrin

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with high grade dysplasia in Barrett's oesophagus but without invasive cancer 2. Aged over 21

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Eradication of high grade dysplasia 2. Prevention of oesophageal cancer 3. Side effect profiles of different types of photodynamic therapy

Secondary

MeasureTime frame
1. Quality of life outcomes 2. Develop novel methods for treatment efficacy 3. Reversal of Barrett's oesophagus

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026