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

Erasmus MC0 个研究点开始时间: 2008年6月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•·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

•·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

发起方