Fujifilm Linked Color Imaging versus high-definition white light endoscopy for the detection of polyps in patients with Lynch syndrome.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Fujifilm 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.
Study objective
Fujifilm Linked Color Imaging versus high-definition white light endoscopy for
the detection of polyps in patients with Lynch syndrome.
Study design
An international, multicenter, parallel randomized controlled trial.
Intervention
Linked Color Imaging (LCI)
Study burden and risks
Each colonoscopy is associated with a small, but not negligible risk of
bleeding (~1%) or perforation (~0.1%). The use of LCI does not increase the
risk of endoscopy.
C2-115 Meibergdreef 11
Amsterdam 1105AZ
NL
C2-115 Meibergdreef 11
Amsterdam 1105AZ
NL
Listed location countries
Age
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
- 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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59002.018.16 |
| OMON | NL-OMON26181 |