The identification and validation of risk factors to enable objective risk-stratification to predict malignant progression in Barrett’s Esophagus: a prospective multi-center study in community hospitals in the Amsterdam regio

Conditions: Barrett's esophagus
Barrett's related neoplasia

Registration Number: NL-OMON24029

Lead Sponsor: Department of Gastroenteroogy and Hepatology, Amsterdam University Medical Centres (Amsterdam UMC)

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 700

Inclusion Criteria

Aged between 18 and 75 years
-Endoscopic and histological evidence of NDBE (defined as intestinal metaplasia without dysplasia) with a circumferential extent of =2 cm and a total maximum extent of =10 cm
-Ability to provide a written informed consent

Exclusion Criteria

-Visible lesions in the esophagus suspicious for neoplasia during the first endoscopy (according to the Paris classification)
-History of HGD or EAC in the esophagus
-Unfit for endoscopic surveillance or inability to obtain biopsies
-History of endoscopic or surgical treatment for esophageal dysplasia or EAC
-History of esophageal surgery other than fundoplication
-Presence of grade C or grade D erosive esophagitis (according to Los Angeles classification)
-Refusal or inability to provide written informed consent

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective: To assess endoscopic and clinical risk factors for progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in a large prospective cohort of BE patients from community hospitals aiding objective risk stratification.

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives: <br>-To acquire high-resolution endoscopic images and videos to aid the training and validation of a CAD system to improve endoscopic detection of early neoplasia in BE patients.<br>-To create a community-based BE surveillance registry to recruit patients for future studies.