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

Completed

Conditions: Barrett's dysplasia
10017990
10017991

Registration Number: NL-OMON46641

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

* 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

Exclusion Criteria

* 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