search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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.



- candidate number28175
- NTR NumberNTR6818
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-nov-2017
- Secondary IDsNL59002.018.16 METC
- Public TitleLinked 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.
- Scientific TitleLinked 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.
- ACRONYMLCI LYNCH
- hypothesis
- Healt Condition(s) or Problem(s) studiedColorectal polyps, Lynch syndrome
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2020
- Target number of participants348
- InterventionsLinked Color Imaging versus high-definition white light endoscopy
- Primary outcomeThe 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 outcomeSecondary 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.
- Timepoints-
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES B. Houwen
- CONTACT for SCIENTIFIC QUERIES B. Houwen
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
FUJIFILM Europe GmbH
- Publicationsnvt
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD10-nov-2017 - 30-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl