Trials / Unknown
UnknownNCT03788824
Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE
Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (estimated)
- Sponsor
- Shandong University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The aim:1) To test the correlation of pCLE-obtained features with histological findings in UC; comparing the real-time conventional colonoscopy Baron score with CLE assessment. 2) To test the accuracy of the investigators previously proposed simplified four-grade classification system of crypt architecture in evaluating inflammation activity in UC by pCLE.
Detailed description
Patients with acute inflammatory infiltrates seen on histological assessment are more likely to experience relapse than are those without infiltrates,studies suggest that severity of inflammation is a risk factor for colorectal neoplasia in UC. The assessment of inflammation activity by conventional colonoscopy is inaccurate in the prediction of acute inflammation in some cases. Confocal laser endomicroscopy (CLE) allows for real-time endoscopy and histological diagnosis of gastrointestinal diseases. In our previous study, we confirmed a simplified four-grade classification system of crypt architecture(Grade A :normal; Grade B: an irregular arrangement of colonic crypts with normal size and shape, and enlarged spaces between crypts; Type C: an enlarged crypt opening and a more irregular crypt arrangement than type B; Type D: crypt destruction and / or crypt abscess) by eCLE in predicting acute inflammation, and found a good correlation with histology. In this study, the investigators aimed to test the accuracy of the proposed tne four-grade classification system in evaluating inflammation activity in UC by pCLE.
Conditions
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2018-12-01
- Completion
- 2019-02-01
- First posted
- 2018-12-28
- Last updated
- 2018-12-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03788824. Inclusion in this directory is not an endorsement.