Endoscopic Tri-Modality Imaging (ETMI) for the detection of early colorectal neoplasia; a multi-center randomized controlled trial

Completed

• Conditions: colon; polyps; 10017990

• Registration Number: NL-OMON30272
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 234

Inclusion Criteria

- Age > 18 years
- Written informed consent
- History of adenomatous polyps
- History of adenocarcinoma of the colon for which a partial colectomy was performed.
- Hereditary non-polyposis colorectal cancer
- A family history of colorectal cancer according to the revised Bethesda criteria

Exclusion Criteria

- Poor bowel preparation
- familial adenomatous polyposis
- history of inflammatory bowel disease
- presence of conditions precluding histological sampling of the colon

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>1) Number of patients with adenomatous polyps/neoplasia detected with<br /><br>Endoscopic Tri-Modality Imaging (ETMI) or Standaard Video Endoscopy (SVE).<br /><br>2) Number of adenomatous polyps/neoplastic lesions detected with ETMI and SVE</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Number of early neoplastic lesions detected with Auto Fluorescence Imaging<br /><br>(AFI) only.<br /><br>2) Reduction of false positives findings after detailed NBI evaluation<br /><br>(differentiating between hyperplastic and adenomatous polyps).<br /><br>3) Patients* health condition.</p><br>