Diagnosis of small colorectal lesions in a non-academic setting.

OPTICAL DIAGNOSIS OF SMALL COLORECTAL POLYPS IN A NON-EXPERT SETTING: A PROSPECTIVE COHORT STUDY.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26990

Enrollment

277

Registered

2011-03-07

Start date

2010-09-07

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

differentiation colorectal lesions white-light narrow-band imaging optical diagnosis

Interventions

All participating endoscopists differentiate colorectal lesions with white-light and NBI and will indicate whether they have high confidence or low confidence in the differentiation. Subsequently, the

whether they will resect and discard it (high confidence, no formal histopathology), resect and send it for histopathology (low confidence, if they cannot decide on the type of polyp or are concerned

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Patients who are advised to undergo colonoscopic surveillance because of: A. A history of adenomatous polyps or colorectal cancer (CRC); B. Symptoms (e.g. change in bowel habits); C. Family history of CRC.

Exclusion criteria

Exclusion criteria: 1. Poor bowel preparation (less than 90% visualization); 2. Polyposis syndromes; 3. Patients with obvious cancer during colonoscopy; 4. Patients with lesions >10mm only; 5. History of inflammatory bowel disease; 6. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy).

Design outcomes

Primary

Measure	Time frame
The accuracy of the optical diagnosis, combining white-light and NBI (using Kudo pit-pattern and VPI), in lesions smaller than 10mm that are differentiated with high confidence.	—

Secondary

Measure	Time frame
1. The percentage of all lesions that is differentiated with high confidence by the endoscopist and the percentage of lesions differentiated with high confidence by white-light only; 2. The difference in accuracy of optical diagnosis of lesions differentiated with high confidence according to size (0-5mm vs. 6-9mm) and the difference in prevalence of (advanced) adenomas in these groups; 3. The difference in accuracy of VPI and Kudo pit pattern for differentiation of small colonic lesions; 4. The percentage of patients who have their surveillance intervals based on optical diagnosis alone, according to Dutch guidelines.	—

Measure

Time frame

1. The percentage of all lesions that is differentiated with high confidence by the endoscopist and the percentage of lesions differentiated with high confidence by white-light only; 2. The difference in accuracy of optical diagnosis of lesions differentiated with high confidence according to size (0-5mm vs. 6-9mm) and the difference in prevalence of (advanced) adenomas in these groups; 3. The difference in accuracy of VPI and Kudo pit pattern for differentiation of small colonic lesions; 4. The percentage of patients who have their surveillance intervals based on optical diagnosis alone, according to Dutch guidelines.

—

Contacts

Public ContactE. Dekker

PO Box 22700

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)