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 Barretts columnar lined oesophagus

ISRCTN	ISRCTN16444200
DOI	https://doi.org/10.1186/ISRCTN16444200
Secondary identifying numbers	Version 3.1

Submission date: 26/01/2006
Registration date: 07/02/2006
Last edited: 28/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Laurence Lovat
Scientific

National Medical Laser Centre
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom

Email	med.laser@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To determine whether photodynamic therapy for high grade dysplasia in Barrett's oesophagus using aminolaevulinic acid has less side effects than photofrin. To develop novel measures of efficacy.
Ethics approval(s)	Berkshire Research Ethics Committee, 13/01/2006, ref: 05/Q1602/193
Health condition(s) or problem(s) studied	High grade dysplasia in Barrett's oesophagus
Intervention	Photodynamic therapy using 5-aminolaevulinic acid versus photofrin
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Aminolaevulinic Photofrin
Primary outcome measure	1. Eradication of high grade dysplasia 2. Prevention of oesophageal cancer 3. Side effect profiles of different types of photodynamic therapy
Secondary outcome measures	1. Quality of life outcomes 2. Develop novel methods for treatment efficacy 3. Reversal of Barrett's oesophagus
Overall study start date	01/02/2006
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	66
Key inclusion criteria	1. Patients with high grade dysplasia in Barrett's oesophagus but without invasive cancer 2. Aged over 21
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	01/02/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

National Medical Laser Centre

London
W1W 7EJ
United Kingdom

Sponsor information

University College London (UK)
University/education

Gower street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Medical Laser Centre (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013		Yes	No

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