Skip to content

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 region

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 region

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24029
Enrollment
700
Registered
2020-03-20
Start date
2020-05-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus

Interventions

None listed

Sponsors

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary Objectives: - 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. - To create a community-based BE surveillance registry to recruit patients for future studies.

Contacts

Public ContactR.E. Pouw

Amsterdam UMC

r.e.pouw@amsterdamumc.nl020-4447135 (research fellow M.W. Chan)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)