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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25050
Enrollment
234
Registered
2007-08-20
Start date
2007-07-10
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Colorectal, neoplasia, adenomas, Colonoscopy, Imaging, Detection, classification Dutch: colon, neoplasie, adenomen, coloscopie, imaging, detectie

Interventions

ETMI tandem colonoscopy: High resolution endoscopy (HRE) followed by autofluorescence imaging (AFI). Conventional colonoscopy: Standard resolution colonoscopy followed by standard resolution colonosco

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients (>18 years) undergoing colonoscopic surveillance because of: a. history of adenomatous polyps. b. history of CRC. c. Hereditary Non-Polyposis Colorectal Cancer d. family history of CRC/adenomas

Exclusion criteria

Exclusion criteria: 1. Poor bowel preparation; 2. Familial Adenomatous Polyposis, attenuated FAP, MYH associated polyposis or hyperplastic polyposis; 3. History of inflammatory bowel disease; 4. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy).

Design outcomes

Primary

MeasureTime frame
Number of adenomas detected by ETMI versus conventional colonoscopy.

Secondary

MeasureTime frame
1. Number of adenomas detected by HRE versus conventional colonoscopy; 2. Miss rate of HRE as followed by AFI (additional yield of AFI); 3. Accuracy of NBI and AFI in discriminating non-neoplastic from neoplastic lesions (Kudo classification and color)

Contacts

Public ContactEvelien Dekker

Academic Medical Center (AMC) Department of Gastroenterology and Hepatology P.O. Box 22660

e.dekker@amc.uva.nl+31 (0)20 5664702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)