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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 PHOTODYNAMIC THERAPY IN THE ERADICATION OF DYSPLASIA IN B...

Update Il y a 4 ans
Reference: EUCTR2005-005528-15

A RANDOMISED CONTROLLED TRIAL TO STUDY THE SIDE EFFECT PROFILE AND TO ESTABLISH MEASURES OF EFFICACY USING PHOTOFRIN OR 5 AMINOLAEVULINIC ACID PHOTODYNAMIC THERAPY IN THE ERADICATION OF DYSPLASIA IN BARRETT’S COLUMNAR LINED OESOPHAGUS

Woman and Man

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Extract

The main aim of this single centre RCT is to determine whether Photodynamic therapy for high grade dysplasia in Barrrett's oesophagus using ALA has less side effects than Photofrin. Primary End Points: • Development of oesophageal stricture. • Development of cutaneous photosensitivity reactions. • Complete ablation of high grade dysplasia. • Failure to eradicate high grade dysplasia. • Relapse to hig hgrade dysplasia. • Development of invasive cancer.

Inclusion criteria

  • High Grade Dysplasia in Barrett's Oesophagus

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