Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03788824|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
pCLE is used to distinguish the inflammation activity of UC, and compared with histology
- A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC. [ Time Frame: 2 years ]
Recruited more than 100 UC patients,pCLE diagnostic criteria was the four-grades crypt architecture classification system ( inactive cases with Grade A or B, active with Grade C or D), histological assessment according to the Geboes Index ( inactive disease with Geboes index ≤ 3.0; active disease with a index > 3.0). Using Spearman's text, calculating the corelation between pCLE real-time finding and the Geboes index, if p<0.05, it means a strong corelation,vice versa. Also for the offline diagnosis.
Also calculate the corelation between white-light colonoscopy (Baron Score) and histopathology.
- Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis. [ Time Frame: 2 years ]Assessment of interobserver variability of pCLE was conducted in a randomized pCLE videos' order by two independent investigators. After a 2-week interval, all pCLE videos were reassessed by the two investigators to evaluate the intraobserver agreement.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788824
|Contact: Yangqing li, PhD. MD||86-531-82169236 ext email@example.com|
|Department of Gastroenterology, Qilu Hospital, Shandong University||Recruiting|
|Jinan, Shandong, China, 250012|
|Contact: Yanqing Li, MD. PhD. 86-531-82169236 ext 82169508 firstname.lastname@example.org|
|Principal Investigator:||Yanqing Li, MD. PhD.||Qilu Hospital, Shandong University|