No registrations found.
ID
Source
Brief title
Health condition
Barrett's esophagus; Barrett's related neoplasia
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Endoscopic surveillance of patients with a Barrett’s esophagus (BE) is crucial to detect neoplasia and its precursor lesions at a stage early enough to be curatively treated, if possible, even endoscopically. The effectiveness and efficiency of the current endoscopic surveillance is questionable as most of the data on risk factors was derived from tertiary care centers or from cohorts with limited surveillance time or surveillance quality. Improving risk-stratification would allow for better endoscopic surveillance. Patients could be stratified into a high-risk or a low-risk group so surveillance intervals can be tailored and the clinical and economic burden of endoscopic surveillance can be reduced.
Study objective
Patients could be stratified into a high-risk or a low-risk group so surveillance intervals can be tailored and the clinical and economic burden of endoscopic surveillance can be reduced.
Study design
Planned surveillance endoscopies according to the Dutch guidelines for NDBE
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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8474 |
| Other | METC AMC : W20_154 # 20.192 |