Assessment of a Consensus Driven Narrow Band Imaging Pattern Classification System in Barrett*s Esophagus

Completed

• Conditions: Barrett's oesophagus; early cancer; 10017990; 10017991

• Registration Number: NL-OMON37521
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Subjects shall be screened according to the following inclusion criteria. An answer of *no* to any inclusion criterion disqualifies a subject from participating in this study.
* Patients age: * 18 years
* Undergoing endoscopy for surveillance or endoscopic treatment of Barrett*s esophagus
* Ability to take oral proton pump inhibitor
* Subject is eligible for treatment and follow-up endoscopy and biopsy as required by the investigational plan
* Ability to discontinue ASA/NSAIDs/Clopidogrel 7 days before and after all ablation procedures
* Ability of provide written, informed consent and understands the responsibilities of trial participation

Exclusion Criteria

Subjects shall be screened according to the following exclusion criteria. An answer of *yes* to any exclusion criterion disqualifies a subject from participating in this study.;* Esophageal stricture preventing passage of endoscope or catheter
* Active erosive esophagitis
* Prior endoscopic therapy with endoscopic mucosal resection, radiofrequency ablation, etc.
* History of esophageal varices or coagulopathy
* Prior radiation therapy to the esophagus, except head and neck region radiation therapy.
* Evidence of esophageal varices during treatment endoscopy
* 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
* The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the current study.
* Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the inter-observer agreement of a consensus driven NBI<br /><br>classification system in BE among experts </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Overall accuracy of the surface patterns in predicting dysplasia<br /><br>* Sensitivity, Specificity, Positive predictive value and negative predictive<br /><br>value of the surface patterns in predicting dysplasia<br /><br>* The accuracy based on confidence and image quality as perceived by the<br /><br>reviewer</p><br>