Clinical Trials Directory

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.

Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE (NCT03788824) · Clinical Trials Directory