Chromoendoscopy-guided confocal laser endomicroscopy in the surveillance of patients with Crohn*s disease

Chromoendoscopy-guided confocal laser endomicroscopy in the surveillance of patients with Crohn*s disease - Crohn's surveillance with CCLE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34757

Enrollment

Registered

2010-03-02

Start date

2010-11-23

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer dysplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The proportion of patients with neoplasia and the mean number of neoplastic lesions per patient.	—

Secondary

Measure	Time frame
- The diagnostic accuracy of CCLE for differentiating neoplastic from non-neoplastic mucosa in patients with Crohns disease. The proportion of neoplasia found in segments with known Crohns 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.	—

Countries

Netherlands

Outcome results