Active — Not RecruitingNot Applicable

Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot

Netherlands60 participantsStarted 2023-10-20

Plain-language summary

The study aims to address the increasing incidence of esophageal cancer and Barrett's esophagus (BE) in the Western world by exploring a more efficient surveillance method. Esophageal adenocarcinoma (EAC) has a poor prognosis if diagnosed late, emphasizing the need for early detection strategies. Current surveillance methods, involving regular endoscopies, are burdensome and costly, particularly for low-risk patients. The study investigates the potential of the Endosign, a Trans Oral Sampling (TOS) device, as an alternative to endoscopic surveillance. The objective is to determine if Endosign can provide sufficient quality samples, containing columnar cells and clot preparations at least 5mm in size, thus offering a reliable substitute for endoscopic sampling. The study includes non-dysplastic and dysplastic BE patients undergoing surveillance or treatment and employs a single-center, prospective feasibility approach.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- Patients age: ≥ 18 years * BE with a maximal extent of ≥4cm * Willingness to undergo an esophagogastroduodenoscopy with sedation * 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: * 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 * Dysphagia/ swallowing disorders * Pregnancy * 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

What they're measuring

to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling.

Timeframe: 1year

Trial details

NCT IDNCT07490340

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-20