PROSPECTIVE RANDOMIZED COMPARISON OF EMR VERSUS EMR FOLLOWED BY PHOTODYNAMIC THERAPY FOR THE TREATMENT OF EARLY BARRETT’S CANCER - p-bec study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

·All patients Age = 18 years treated for high-grade intraepithelial dysplasia and/or mucosal cancer with EMR, in whom follow-up biopsies do not show remaining severe neoplasia
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

·Patients unable or unwilling to give informed consent
·A Barrett segment longer than 7 cm
·Coagulopathy uncorrected at the time of endoscopy or thrombocytopenia (<50 x 109 / l thrombocytes)
·Patients with elevated liver enzymes (more than 2 times the upper limit normal)
·Patients with known porphyria, achalasia, intolerance to 5-ALA, connective tissue disease, esophagial atresia, renal insufficiency, pre-existing cardiovascular disease, and prior caustic esophagitis
·Patients previously treated for dysplasia or cancer of the esophagus
·Patients previously treated with radiotherapy involving the mediastinum or surgical treatment of the esophagus
·Pregnant or lactating women, or women of childbearing potential not taking adequate contraceptives

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this study is to evaluate the value of photodynamic therapy after complete EMR in patients with prior high-grade dysplasia and mucosal cancer in Barrett’s esophagus.;Secondary Objective: ·To determine morbidity, mortality, and procedural failure rates, for PDT.<br>·To establish recurrence rates of neoplasia after EMR.<br>;Primary end point(s): The primary endpoint of this study will be the recurrence rate of histological proven severe dysplasia or cancer after EMR or EMR and PDT. Recurrent disease is defined as the presence of severe neoplastic tissue in either visible recurrent lesions or in random biopsies taken at surveillance endoscopies in the Barrett segment or in the neo-squamous epithelium. The primary endpoint will be measured 3 and 6 month after randomization, and subsequently every 6 months until detection of high grade dysplasia/cancer, or 2 years of follow up.

Secondary Outcome Measures

Name	Time	Method

Related Trials