Wide Area Transepithelial sample Esophageal Biopsy combined with Computer assisted 3-Dimensial Tissue Analysis (WATS) for the detection of High Grade Esophageal Dysplasia and Adenocarcinoma: A multicenter prospective, randomized, tandem study - WATS European 810 trial 2017

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

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•* Patients age: * 18 years
•* Patients should have a history of Barrett*s associated esophageal neoplasia (either low or high-grade dysplasia on biopsy without visible lesions or well to moderately differentiated mucosal adenocarcinoma, without lymphovascular invasion after EMR) confirmed on histology
•* Willingness to undergo both WATS and random forceps biopsies while undergoing conventional EGD with sedation
•* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
•* Only patients without visible lesions at the time that they undergo both random forceps biopsies and WATS testing of the esophagus will be included in this study

•* BE length < 2 cm circumferential extent or > 10 cm total extent
•* Patients within six weeks of receiving targeted forceps biopsies and/or EMR
•* Patients with visible mucosal lesion according to the Paris classification at the time of the WATS and random biopsy testing
•* Patients with visible lesions that are either submucosal or covered with a clinically intact epithelium
•* History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR), except for Nissen fundoplication
•* Patients who have already undergone endoscopic ablative therapies
•* Coagulopathy with INR >2.0, thrombocytopenia with platelet counts < 50,000
•* The subject is pregnant or planning a pregnancy during the study period
•* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines

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