The aims of this study are to assess the prevalence of dysplasia and cancer in Crohn*s disease and to evaluate the accuracy of CCLE during colonoscopy surveillance in Crohn*s disease.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of patients with neoplasia and the mean number of neoplastic
lesions per patient.
Secondary outcome
- The diagnostic accuracy of CCLE for differentiating neoplastic from
non-neoplastic mucosa in patients with Crohn*s disease. The proportion of
neoplasia found in segments with known Crohn*s disease.
- The diagnostic accuracy of CCLE to differentiate DALMs from ALMs.
- The inter- and intraobserver variability assessing confocal images with and
without matching endoscopic images.
Background summary
The increased cancer risk in longstanding ulcerative colitis (UC) is well
established. In comparison, the risk of colorectal cancer in Crohn*s disease
(CD) is not as well studied and remains subject of discussion. Furthermore,
risk estimates in CD differ considerably and it remains unclear whether
dysplasia or cancer arises only in segments with known CD.
In addition, once suspicious lesions are detected endoscopically in
inflammatory bowel disease, it is difficult to differentiate lesions from DALMs
(requiring proctocolectomy), and from sporadic ALMs (requiring endoscopical
resection).
Recent studies have suggested that chromoendoscopy-guided confocal laser
endomicroscopy (CCLE) is a more efficient surveillance strategy than standard
endoscopy in patients with ulcerative colitis, but this has to our knowledge
never been reported in Crohn*s surveillance.
Study objective
The aims of this study are to assess the prevalence of dysplasia and cancer in
Crohn*s disease and to evaluate the accuracy of CCLE during colonoscopy
surveillance in Crohn*s disease.
Study design
In 4 IBD-referral centres, patients with longstanding Crohn*s colitis in
remission undergoing surveillance colonoscopy will be asked to participate in
the study. Chromoendoscopy (CE) will be used for detection and differentiation
and confocal laser endomicroscopy (CLE) for differentiation of suspicious
lesions.
After examination with CCLE, targeted biopsies will be taken of each detected
lesion and of mucosa adjacent to each detected lesion. Lastly, 4 quadrant
random biopsies each 10cm of the colon will be taken.
Study burden and risks
The endoscopic procedure is comparable to the standard procedure for regular
patient care except that procedural time is possibly increased up to a maximum
of 15 minutes. Increasing the procedural time does not increase the risk of
complication. The risk of complication in a diagnostic colonoscopy is minimal
(<1%).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients diagnosed with Crohn*s colitis in remission, with at least 50 cm of the colon involved.
Indication for surveillance colonoscopy (disease duration of more than 8 years or diagnosed with concomitant primary sclerosing cholangitis)
Age >18 years
Exclusion criteria
Contraindications (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or renal failure) for the use of intravenous fluorescein
Non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30252.018.09 |