Crohn's, IBD, dysplasia, chromoendoscopy, endomicroscopy. Crohn, IBD, dysplasie, chromoendoscopie, endomicroscopie
Conditions
Interventions
Each part of the colon (cecum, ascending, transverse, descending, sigmoid colon and rectum) will be sprayed with 0.1% methylene blue solution on withdrawal of the endoscope. In case of detected lesion
Sponsors
Academic Medical Centre, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with Crohn’s colitis that are in remission; 2. Patients who have Crohn’s disease in at least 50 cm of the colon, based on clinical symptoms, endoscopy and histopathological diagnosis; 3. Indication for surveillance colonoscopy (disease duration of more than 8 years or diagnosed with concomitant PSC); 4. Age >18 years.
Exclusion criteria
Exclusion criteria: 1. Contraindications (allergy, pregnancy or breastfeeding, severe cardiopulmonary disease or pre-existent renal disease) for the use of intravenous fluorescein; 2. Known non-correctable coagulopathy that precludes taking biopsies (international normalized ratio >2; or platelet count <90*109). Patients who take anticoagulants will have their international normalized ratio evaluated prior to the colonoscopy; 3. No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with neoplasia; 2. Mean number of neoplastic lesions per included patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic accuracy (defined as sensitivity, specificity and overall accuracy) of CCLE for the differentiation of neoplastic and non-neoplastic mucosa, using final histopathology as reference standard diagnosis; 2. The number of neoplastic lesions found in segments known with Crohn’s disease and in segments without Crohn’s disease. Crohn’s disease is either macroscopically diagnosed or confirmed in histopathology; 3. Diagnostic accuracy of CCLE to differentiate between DALMs and ALMs, using the abovementioned definition as reference standard: DALMs are histologically proven neoplastic lesions with neoplasia in the adjacent ‘apparently normal’ mucosa, whereas ALMs appear endoscopically as sporadic adenoma and do not demonstrate neoplasia in the adjacent mucosa; 4. The yield of random biopsies, defined by the number of patients with neoplasia detected by random biopsies only (confirmed by histopathology) compared to the total number of patients with neoplasia; 5. The inter- and intraobserver variability assessing confocal images with and without matching endoscopic images. | — |
Contacts
Public ContactT. Kuiper
Meibergdreef 9
Outcome results
None listed