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 - RCT of ALA and Photofrin PDT for HGD in Barrett's Oesophagus

Phase 1

• Conditions: High Grade Dysplasia in Barrett's Oesophagus

• Registration Number: EUCTR2005-005528-15-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-19
• Study Completion: 2015-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

1.Patients will be recruited from those referred to the National Medical Laser Centre for management of HGD in BE.
2.Patients with biopsy proven Barrett’s Columnar Lined Oesophagus and high-grade dysplasia confirmed by 2 independent pathologists, and no evidence of invasive cancer. Biopsies will be taken at surveillance endoscopy from each quadrant of the oesophagus every 2 cm through the length of the Barrett’s Oesophagus segment.
3.Patients with a visible distinct nodule of HGD will be eligible for inclusion following endoscopic mucosal resection or other ablative therapy to this nodule provided residual HGD remains in the patient’s Barrett’s segment.
4.Patients may have an endoscopic ultrasound to confirm non-invasive disease as clinically indicated.
5.Patients to be double stratified into:
(a) Short or Long Segment BE: Short segment defined as 6 cm or less (single length treatment) and Long segment defined as >6cm but up to 13cm (double length treatment)
(b) Single or Multiple sites of high grade dysplasia.
5The maximum length of Barrett’s oesophagus eligible for inclusion into the study will be 13cm.
6Patients must have no contraindications to endoscopy.
7Males and non-pregnant females over the age of 21 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
8Patients must sign an informed consent form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Presence of invasive carcinoma of the oesophagus.
2History of severe cardiovascular disease, severe angina, congestive heart failure, or recent syncope of cardiovascular origin.
3Patients presenting with abnormal cardiac signs or symptoms and signs of congestive heart failure on physical examination.
4Patients with orthostatic hypotension resistant to hydration.
5Patients in whom endoscopy is contraindicated.
6Patients who have a history of porphyria, or hypersensitivity to porphyrins.
7Patients taking depot preparations of psychotropic medication
8Patients with a WBC <2x109/L.
9Patients with a platelet count <50x109/L.
10Patients with a prothrombin time >1.5 times the upper limit of normal.
11Patients with impaired renal and/or hepatic function at time of entry into the study (total serum bilirubin >50 mcmol/L, serum creatinine >200 mcmol/L, alkaline phosphatase (of hepatic origin) and/or ALT >2 times upper limit of normal).
12Patients are not allowed to receive concurrent chemotherapy, or radiation therapy or chemotherapy within 4 weeks of entry into this study.
13Patients with prior PDT for Barrett’s Columnar Lined Oesophagus.
14Barrett’s Oesophagus greater than 13cm in length.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified