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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. Identifier: NCT03788824
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief 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.

Condition or disease

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

pCLE group
pCLE is used to distinguish the inflammation activity of UC, and compared with histology

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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
sample for histological examination

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Inclusion Criteria:

  • Male or Female aged 18-80;
  • patients previously or in-process diagnosed as Ulcerative Colitis

Exclusion Criteria:

  • Patients with gastrectomy, acute GI bleeding, and advanced esophageal cancer;
  • Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), lactation, food retention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
  • Inability to provide informed consent and other situations that could interfere with the examination protocol.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03788824

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Contact: Yangqing li, PhD. MD 86-531-82169236 ext 82169508

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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD. PhD.    86-531-82169236 ext 82169508   
Sponsors and Collaborators
Shandong University
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Principal Investigator: Yanqing Li, MD. PhD. Qilu Hospital, Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University Identifier: NCT03788824    
Other Study ID Numbers: 2014SDU-QILU-G05
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Keywords provided by Yanqing Li, Shandong University:
Ulcerative Colitis
probe-based Confocal Laser Endoscopy
Inflammation Activity
Additional relevant MeSH terms:
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Colitis, Ulcerative
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases