Endoscopic Tri-Modal Imaging (ETMI) for the detection and classification of early colorectal neoplasia: a multicentre randomised controlled trial
Completed
- Conditions
- Colorectal neoplasiaCancerNeoplasia
- Registration Number
- ISRCTN64206478
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 234
Inclusion Criteria
Patients (greater than 18 years) undergoing colonoscopic surveillance because of:
1. History of adenomatous polyps
2. History of colorectal cancer (CRC)
3. Hereditary non-polyposis colorectal cancer
4. Family history of CRC/adenomas
Exclusion Criteria
1. Poor bowel preparation
2. Familial adenomatous polyposis (FAP), attenuated FAP, MutY human homologue (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
Name Time Method umber of adenomas detected by ETMI versus conventional colonoscopy
- Secondary Outcome Measures
Name Time Method 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 narrow band imaging (NBI) and AFI in discriminating non-neoplastic from neoplastic lesions (Kudo classification and colour)