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)


Observational study;
Confocal endomicroscopy in the diagnosis of colorectal neoplasia.



- candidate number2780
- NTR NumberNTR1094
- ISRCTNWordt niet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2007
- Secondary IDs072090 MEC, academisch ziekenhuis Maastricht
- Public TitleObservational study;
Confocal endomicroscopy in the diagnosis of colorectal neoplasia.
- Scientific TitleObservational study;
Combined pan-chromoendoscopy and confocal endomicroscopy for the diagnosis of colorectal neoplasia in subjects at high-risk for colorectal cancer.
- ACRONYMN/A
- hypothesisTo prospectively assess the efficacy of combined pan-chromoendoscopy and confocal colonoscopy for the detection of neoplastic lesions in patients at high-risk for CRC.
Two issues will be addressed:
1. Does pan-colonic chromoendoscopy improve the diagnostic yield of colonic polyps (and in particular flat lesions) as compared to conventional colonoscopy?;
2. Does pan-colonic chomoendoscopy combined with confocal endomicroscopy result in higher diagnostic accuracy of colonic lesions as compared to conventional colonoscopy with biopsies?
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Adenomatous polyps
- Inclusion criteria1. Clinical diagnostic criteria for either HNPCC (Amsterdam II criteria , Bethesda criteria or genetic criteria) or familial colorectal cancer type X – (1) CRC diagnosed age < 50 years;
2. at least 2 first-degree relatives with CRC regardless of age;
3. 1 first-degree and 1 second-degree relative with CRC regardless of age.
- Exclusion criteria1. Age < 18 years, presence of inflammatory bowel disease, or known polyposis syndromes;
2. Patients with incomplete endoscopic procedure due to anatomic or technique-related factors.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2007
- planned closingdate1-dec-2008
- Target number of participants60
- InterventionsBoth techniques (conventional colonoscopy and confocal endomicroscopy) are routinely used in clinical practice at the Department of Gastroenterology of our hospital. In this regard, patients participating in the study will not undergo additional (invasive) examination. As the duration of the chromoscopy-guided confocal endomicroscopy procedure is somewhat longer than the standard procedure, the patient-burden will possibly increase, mainly due to the ‘back-to-back’ evaluation. The potential advantage is the achievement of higher diagnostic accuracy of preneoplastic lesions in this high-risk population.
During confocal endomicroscopy fluorescein will be administred intravenously, to generate confocal images. This is a safe contrast-agent which has been previously used for the diagnosis of ophtalmologic diseases (e.g. corneal infections). Additionally, fluorescein has been already used in more than 1000 patients undergoing confocal endomicroscopy, without relevant adverse events. Allergic reactions, in particular nausea seldom occur. Also, transient yellow discoloration of urine and skin may occur.


The general risks associated to the colonoscopic procedure are detailed in the endoscopy-folder of the GI Endoscopy Unit of the University Hospital Maastricht.
- Primary outcomeThe 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.
- Secondary outcomeSecondary outcome measures assessing the diagnostic accuracy of combined pan-chromoendoscopy and confocal endomicroscopy are: total number of lesions detected; number of adenomas; number of advanced adenomas; number of flat lesions detected.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S. Sanduleanu
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Ad Masclee
- Sponsor/Initiator University Maastricht (UM), department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht, department of Gastroenterology and Hepatology
- Publications1. Confocal laser endomicroscopy: technical status and current indications. Endoscopy 2006;38(12):1275-83. Hoffman, A., Goetz, M., Vieth, M., Galle, P.R., Neurath, M.F., Kiesslich, R;
2. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology 2004;127(3):706-13. Kiesslich, R., Burg, J., Vieth, M., Gnaendiger, J., Enders, M., Delaney, P., Polglase, A., McLaren, W., Janell, D., Thomas, S., Nafe, B., Galle, P.R., Neurath, M.F;
3. The role of high-magnification-chromoscopic colonoscopy in hereditary nonpolyposis colorectal cancer screening: a prospective “back-to-back” endoscopic study.
Am J Gastroenterol 2005; 100:2167-73 Hurlstone, D.P., Karajeh, M., Cross, S.S., McAlindon, M.E., Brown, S., Hunter, M.D., Sanders, D.S.
cancer in vivo.
Gastroenterology 2004;127(3):706-13. Kiesslich, R., Burg, J., Vieth, M., Gnaendiger, J., Enders, M., Delaney, P., Polglase, A., McLaren, W., Janell, D., Thomas, S., Nafe, B., Galle, P.R., Neurath, M.F.
- Brief summaryRationale:
Colonoscopic surveillace is mandatory in patients at high-risk for colorectal cancer. However some practical issues makes this difficult (e.g. high frequency follow-up, high rate of flat adenomas - a notorious source of interval cancer - , and unnecessary removal of non-neoplastic lesions). Imperative to these data is to improve the accuracy of colonoscopic procedures. The role of confocal endomicroscopy in surveillance of patients at high-risk for CRC has been recently explored. It is presently not clear whether this technique has incremental benefit when added to traditional colonoscopic techniques. Objective:
Two issues will be addressed:
1. does pan-colonic chromoendoscopy improve the diagnostic yield of colonic polyps (and in particular flat lesions) as compared to conventional colonoscopy?;
2. does pan-colonic chomoendoscopy combined with confocal endomicroscopy result in higher diagnostic accuracy of colonic lesions as compared to conventional histology?;
Study design:
60 patients from either HNPCC families or with familial CRC type X attending for colonoscopic surveillance will be examined twice, first with conventional white-light endoscopy and a second pass with pan-chromoscopy-guided endomicroscopy, in a segmental ‘back-to-back’ fashion. All polyps detected will be removed for histopathological analysis.
The following hypotheses will be tested:
Combined pan-chromoscopic colonoscopy and confocal endomicroscopy result in:
1. Higher adenoma yield, in particular of flat adenomas, mainly due to chromoendoscopy;
2. Improved diagnostic accuracy of neoplastic lesions, in particular:
a. reduction of overdiagnosis;
b. e.g. unnecessary polypectomy of non-neoplastic (low-risk) lesions;
c. reduction of underdiagnosis;
d. e.g. biopsy instead of resection of neoplastic lesions (in particular, the case of admixed serrated adenomas, or in case of sampling errors, etc.) as compared to conventional colonoscopy.
- Main changes (audit trail)
- RECORD1-okt-2007 - 12-nov-2008


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