Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy
ConditionBarrett Esophagus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any participant 18 years and above, with ultralong-segment Barrett's esophagus and clinically fit for an endoscopy
Ability to provide informed consent
Disqualifiers
Individuals with a diagnosis of an oro-pharynx, esophageal or gastro-esophageal tumor (T2 staging and above), or symptoms of dysphagia
Esophageal varices or stricture requiring dilatation of the esophagus
Individuals who have had a cerebrovascular event < 6 months prior where their swallowing has been affected
Patients who have had previous treatments such as Photodynamic therapy (PDT), Radiofrequency ablation (RFA) or Argon Plasma Coagulation (APC) for dysplastic Barrett's esophagus
Trial design
Design model
Single group
Treatments tested in this trial
EndoSign
DeviceThe EndoSign cell collection device is a non-endoscopic capsule sponge device used to collect pan-esophageal samples. The Endosign procedure consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Seven minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter is retrieved by pulling on the string. Upon retrieval the capsule-sponge scrapes against the surface of the top of the stomach and esophagus and collects epithelial cells. The capsule-sponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests.
Treatment groups
137 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Concordance between EndoSign and upper endoscopy to detect dysplasia and/or esophageal adenocarcinoma
We will determine the concordance between the EndoSign test and upper endoscopy by an expert endoscopist to detect dysplasia and/or esophageal adenocarcinoma in patients with an ultralong-segment Barrett's esophagus.
Time frame
3 yearsSecondary outcomes
1
Patient rating of both the EndoSign procedure and upper endoscopy on an experience scale
Patients with an ultralong Barrett esophagus will rate their experience with both the Endosign procedure and endoscopy on a scale from 1 - 10, with 1 being the worst experience ever and 10 the best experience ever. These results will be compared to assess which procedure is generally more acceptable to patients.
Time frame
3 years2
Sensitivity & specificity
To determine the sensitivity and specificity of the EndoSign to detect any form of dysplasia or esophageal adenocarcinoma in a cohort of ultralong-segment Barrett's esophagus patients.
Time frame
3 years3
Additional value of p53 immunohistochemistry
To determine the additional value of p53 immunohistochemistry in risk stratifying patients with ultralong-segment Barrett's esophagus.
Time frame
3 years4
Accuracy of a new risk stratification model for neoplastic progression
We will determine the accuracy of a newly developed risk stratification model that predicts which patients with an ultralong-segment Barrett's esophagus have the highest chance of neoplastic progression. We will use both clinical risk factors and p53 immunohistochemistry.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov