Combined pan-chromoendoscopy and confocal endomicroscopy for the diagnosis of colorectal neoplasia in subjects at high-risk for colorectal cancer

Combined pan-chromoendoscopy and confocal endomicroscopy for the diagnosis of colorectal neoplasia in subjects at high-risk for colorectal cancer - Confocal endomicroscopy in the diagnosis of colorectal neoplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31853

Enrollment

Registered

2007-11-15

Start date

2007-12-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

familial colorectal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 60 asymptomatic patienten, fulfilling the clinical diagnostic criteria for either HNPCC (Amsterdam II criteria, Bethesda criteria or genetic criteria) or familial colorectal cancer type X * ( i) CRC diagnosed age

Exclusion criteria

Exclusion criteria: The following exclusion criteria will be used: age

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be the number of patients with at least one adenoma after conventional colonoscopy compared with the number of patients with at least one adenoma after pan-chromoendoscopy-guided endomicroscopy. We presume that 10-28% of the participants will have at least one adenoma after conventional colonoscopy. For a power (1-b) of 80% to detect a 100% increase in the number of patients with at least one adenoma after pan-chromoendoscopy (assuming an adenoma prevalence of 10%), with a significance level (a) of 5%, at least 60 patients need to be included.	—

Measure

Time frame

The primary outcome measure will be the number of patients with at least one adenoma after conventional colonoscopy compared with the number of patients with at least one adenoma after pan-chromoendoscopy-guided endomicroscopy. We presume that 10-28% of the participants will have at least one adenoma after conventional colonoscopy. For a power (1-b) of 80% to detect a 100% increase in the number of patients with at least one adenoma after pan-chromoendoscopy (assuming an adenoma prevalence of 10%), with a significance level (a) of 5%, at least 60 patients need to be included.

—

Secondary

Measure	Time frame
Secondary outcome measures assessing the diagnostic accuracy of combined pan-chromoendoscopy and confocal endomicroscopy as compared to conventional colonoscopy with biopsies are: total number of lesions detected; number of flat lesions, number of adenomas; number of advanced adenomas detected.	—

Countries

Netherlands

Outcome results