High Grade Dysplasia in Barrett's Oesophagus
Conditions
Interventions
Trade Name: Levulan (for dermatological use not internal use)
Product Name: 5 aminolaevulinic acid (ALA)
Pharmaceutical Form: Granules for oral solution
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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. 5 The maximum length of Barrett’s oesophagus eligible for inclusion into the study will be 13cm. 6 Patients must have no contraindications to endoscopy. 7 Males and non-pregnant females over the age of 21 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception. 8 Patients 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
Exclusion criteria: 1 Presence of invasive carcinoma of the oesophagus. 2 History of severe cardiovascular disease, severe angina, congestive heart failure, or recent syncope of cardiovascular origin. 3 Patients presenting with abnormal cardiac signs or symptoms and signs of congestive heart failure on physical examination. 4 Patients with orthostatic hypotension resistant to hydration. 5 Patients in whom endoscopy is contraindicated. 6 Patients who have a history of porphyria, or hypersensitivity to porphyrins. 7 Patients taking depot preparations of psychotropic medication 8 Patients with a WBC 1.5 times the upper limit of normal. 11 Patients 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). 12 Patients are not allowed to receive concurrent chemotherapy, or radiation therapy or chemotherapy within 4 weeks of entry into this study. 13 Patients with prior PDT for Barrett’s Columnar Lined Oesophagus. 14 Barrett’s Oesophagus greater than 13cm in length.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ; Secondary Objective: Secondary End Points: • Comparison of all other side effects of the medications. • Assessment of patient Quality of life before, during and after therapy. • Ability of optical measurements and molecular markers to predict success or failure of this therapy. • Presence of buried subsquamous glands. ; Primary end point(s): Primary End Points: • Development of oesophageal stricture. • Development of cutaneous photosensitivity reactions. • Complete ablation of high grade dysplasia (HGD). • Failure to eradicate HGD. • Relapse to HGD. • Development of invasive cancer. | — |
Countries
United Kingdom
Outcome results
None listed