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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30272

Enrollment

234

Registered

2006-12-04

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

colon polyps

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1) Number of patients with adenomatous polyps/neoplasia detected with Endoscopic Tri-Modality Imaging (ETMI) or Standaard Video Endoscopy (SVE). 2) Number of adenomatous polyps/neoplastic lesions detected with ETMI and SVE	—

Secondary

Measure	Time frame
1) Number of early neoplastic lesions detected with Auto Fluorescence Imaging (AFI) only. 2) Reduction of false positives findings after detailed NBI evaluation (differentiating between hyperplastic and adenomatous polyps). 3) Patients* health condition.	—

Countries

Netherlands

Outcome results