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.
ID
Bron
Verkorte titel
Aandoening
Barrett's esophagus; Barrett's related neoplasia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Planned surveillance endoscopies according to the Dutch guidelines for NDBE
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8474 |
| Ander register | METC AMC : W20_154 # 20.192 |