Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE

NCT03788824 | Unknown DMC

• 1 other identifier: 2014SDU-QILU-G05
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

Ulcerative Colitis; probe-based Confocal Laser Endoscopy; Inflammation Activity; Histology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.

  2 years

Study Arms (1)

pCLE group

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

sample for histological examination

MeSH Terms

Conditions

Inflammation; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yanqing Li, MD. PhD.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangqing li, PhD. MD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: December 28, 2018
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

CN (1)