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Trans-Oral Sampling as an alternative Surveillance of Barrett*s Esophagus Pilot: The TOSS pilot-study

Trans-Oral Sampling as an alternative Surveillance of Barrett*s Esophagus Pilot: The TOSS pilot-study - TOSS pilot study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56023
Enrollment
60
Registered
2023-08-14
Start date
2023-10-20
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Barrett Esophagus dysplasia

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients age: >= 18 years - BE with a maximal extent of >=4cm - Cohort 1: Patients referred for endoscopic treatment of HGD or EAC - Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the previous 18 months, undergoing endoscopic surveillance - Ability to give written, informed consent and understand the responsibilities of participation

Exclusion criteria

Exclusion criteria: • Patients within eight weeks after endoscopy with biopsies and/or ER • History of esophageal or gastric surgery other than Nissen fundoplication • History of esophageal ablation or dilation therapy • Presence of esophageal varices and/or suspected portal hypertension • pregnancy • present Dysphagia/ swallowing disorders at the time of screening and participation • Patients with known or suspected anatomical abnormalities of the esophagus or stomach • Patients taking anti-thrombotic drugs that cannot be temporarily discontinued • 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

Design outcomes

Primary

MeasureTime frame
The amount of samples collected with the Cytosponge that contain columnar cells and are processed to clot preparations that are at least 5mm in size.

Secondary

MeasureTime frame
The number of successful Cytosponge study procedures. The concordance between the pathology review of endoscopic samples and samples collected with the Cytosponge The concordance between 2 samples of the same subject taken with the Cytosponge

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)