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

Recruiting
Conditions
Colorectal, neoplasia, adenomas, Colonoscopy, Imaging, Detection, classificationDutch: colon, neoplasie, adenomen, coloscopie, imaging, detectie
Registration Number
NL-OMON25050
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
234
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

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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of adenomas detected by ETMI versus conventional colonoscopy.
Secondary Outcome Measures
NameTimeMethod
1. Number of adenomas detected by HRE versus conventional colonoscopy;<br>2. Miss rate of HRE as followed by AFI (additional yield of AFI);<br>3. Accuracy of NBI and AFI in discriminating non-neoplastic from neoplastic lesions (Kudo classification and color)
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