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Linked Color Imaging versus high-definition white light endoscopy for the detection of polyps in patients with Lynch syndrome. An international, multicenter, parallel randomized controlled trial.

Linked Color Imaging versus high-definition white light endoscopy for the detection of polyps in patients with Lynch syndrome. An international, multicenter, parallel randomized controlled trial. - LCI LYNCH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50151
Enrollment
134
Registered
2017-04-26
Start date
2018-01-23
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Lynch syndrome polyps

Interventions

Linked Color Imaging (LCI)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6, PMS2) - Surveillance colonoscopy for Lynch syndrome. - Age >18 years

Exclusion criteria

Exclusion criteria: - Recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia. - Colonoscopy planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia. - Patients with a concurrent diagnosis of (serrated) polyposis syndrome or inflammatory bowel disease. - Patients who are unwilling or unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the polyp detection rate of HD-WLE and LCI. Polyp detection rates are defined as the number of patients with at least 1 polyp detected during the inspection divided by the total number of patients included in the study.

Secondary

MeasureTime frame
- The difference in mean number of polyps between HD-WLE and LCI - The difference in adenoma detection rate between HD-WLE and LCI - The difference in mean number of adenomas between HD-WLE and LCI - The difference in mean number of serrated polyps between HD-WLE and LCI - The mean duration of both endoscopic procedures LCI vs. HD-WLE: time for inspection and time for performing endoscopic resection - The sensitivity, specificity and accuracy of optical diagnosis on a per polyp basis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)