No registrations found.
ID
Source
Brief title
Health condition
The missing rate of colorectal polyps
Sponsors and support
Academic Medical Centre
Intervention
Outcome measures
Primary outcome
The aim of the present study is to compare polyp detection rates of LCI with high-definition white light endoscopy (HD-WLE) in patients with Lynch syndrome in a parallel, international, multicenter, randomized controlled colonoscopy trial.
Secondary outcome
Secondary objectives of this study are comparisons of mean number of detected polyps, adenoma detection rate, mean umber of adenomas, mean number of serrated polyps, mean duration of procedures, and sensitivity, specificity and accuracy of optical diagnosis on a per polyp basis.
Background summary
Rationale: Linked Color Imaging is a push-button endoscopic imaging technique developed to enhance the visibility of the vasculature and architecture of the mucosal surface by narrowing the spectrum of absorbed light. Compared to High-Definition White Light Endoscopy, mucosal surface patterns are better visualized and this could potentially increase the detection of polyps by improving the visibility of colorectal polyps. Patients with Lynch syndrome have accelerated carcinogenesis and even the smallest polyps have malignant potential. Increasing polyp detection rates with new imaging techniques is therefore of importance.
Objective: To compare polyp detection rates of Linked Color Imaging with High-Definition White Light Endoscopy during surveillance colonoscopy in Lynch patients
Study design: international, multicentre, parallel, randomized controlled trial
Study population: Patients diagnosed with Lynch syndrome aged ≥ 18 years old
Intervention: Linked Color Imaging colonoscopy or High-Definition White Light Endoscopy
Main study parameters/endpoints: Polyp detection rate of Linked Color Imaging versus High-Definition White Light Endoscopy
Nature and extent of the burden and risks associated with participation, benefit
and group relatedness: Each colonoscopy is associated with a small, but not negligible
risk of bleeding (~1.5%) or perforation (~0.1%). The use of LCI does not increase the
risk of endoscopy.
Study design
-
Intervention
Linked Color Imaging versus high-definition white light endoscopy
B. Houwen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5667865
b.b.houwen@amc.uva.nl
B. Houwen
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5667865
b.b.houwen@amc.uva.nl
Inclusion criteria
-Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6, PMS2)
- Age >18 years
- Surveillance colonoscopy for Lynch syndrome.
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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6601 |
| NTR-old | NTR6818 |
| CCMO | NL59002.018.16 |
| OMON | NL-OMON50151 |