Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE

Last updated: December 23, 2018
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Inflammatory Bowel Disease

Inflammation

Treatment

N/A

Clinical Study ID

NCT03788824
2014SDU-QILU-G05
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female aged 18－80;

  • patients previously or in-process diagnosed as Ulcerative Colitis

Exclusion

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, foodretention, oesophageal stenosis, postoperative cases, leiomyoma, impaired renalfunction (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergyto fluorescein sodium;

  • Inability to provide informed consent and other situations that could interfere withthe examination protocol.

Study Design

Total Participants: 70
Study Start date:
June 01, 2014
Estimated Completion Date:
February 28, 2019

Study 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.

Connect with a study center

  • Department of Gastroenterology, Qilu Hospital, Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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