Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE

Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy

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.

Study Overview

• Status: Unknown
• Conditions: Inflammation

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Yangqing li, PhD. MD; Phone Number: 82169508 86-531-82169236; Email: liyanqing@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.	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.	2 years

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Yanqing Li, MD. PhD., Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: December 23, 2018
• First Posted (ACTUAL): December 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Histology; probe-based Confocal Laser Endoscopy; Inflammation Activity
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Inflammation; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2014SDU-QILU-G05