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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37521

Enrollment

Registered

2012-05-14

Start date

2012-07-09

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Barrett's oesophagus early cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
* Overall accuracy of the surface patterns in predicting dysplasia * Sensitivity, Specificity, Positive predictive value and negative predictive value of the surface patterns in predicting dysplasia * The accuracy based on confidence and image quality as perceived by the reviewer	—

Primary

Measure	Time frame
To determine the inter-observer agreement of a consensus driven NBI classification system in BE among experts	—

Countries

Netherlands

Outcome results