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Study on narrow band imaging versus conventional colonoscopy for polyps detection in patients with positive fecal occult blood test undergoing colonoscopy screening

Narrow band imaging versus high definition white light colonoscopy for the detection of colorectal polyps in patients with positive fecal occult blood test undergoing colonoscopy screening: results of a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66817054
Enrollment
600
Registered
2013-03-12
Start date
2008-05-01
Completion date
Unknown
Last updated
2016-11-07

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

Conditions

Patients with positive FOBT harbour a risk of colorectal cancer of about 5% and of advanced adenomas of about 40% Cancer Malignant neoplasm of colon and rectum

Interventions

A total of six experienced endoscopists each having performed > 5000 standard colonoscopies and > 50 NBI colonoscopies participate in the study. For all the study procedures, high-resolution wide-ang
the entire procedure time and the withdrawal phase will be timed by the endoscopist by using a stopwatch, which will be blocked whenever a polyp will be found and removed. Bowel preparation will be ev

Sponsors

University of Turin (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All consecutive patients aged 55-64 years, either sex, referred to the Endoscopic Units of Torino and Novara for screening colonoscopy due to positive fecal occult blood test (FOBT)

Exclusion criteria

Exclusion criteria: 1. Use of antiplatelet agents or anticoagulants that preclude removal of polyps 2. Refusal to participate or inability to give informed consent

Design outcomes

Primary

MeasureTime frame
To evaluate whether the use of NBI might increase the detection rate of advanced adenomas compared with High Definition White Light colonoscopy (HD-WL); so, the primary outcome measures will be the overall number of advanced adenomas detected in both groups and the number of advanced adenomas per patient. The definition of advanced adenoma includes all adenomas with a diameter = 1 cm and/or villous component of at least 25%, and/or high-grade dysplasia.

Secondary

MeasureTime frame
To compare the ADR, defined as the percentage of patients with =1 adenomas, and the total number of adenomas. So, the secondary outcome measures will be the overall number of patients with at least one adenoma in both groups and total number of adenomas found in the patients according to their group.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026