Clinical trial NCT03788824: Evaluation of Inflammation Activity in Ulcerative Colitis by pCLE
Official title: Evaluation of Inflammation Activity in Ulcerative Colitis by Probe-based Confocal Laser Endomicroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Keywords: Ulcerative Colitis
probe-based Confocal Laser Endoscopy
Inflammation Activity
Histology
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A valuable realtime- and offline- diagnosis of pCLE in evaluating the inflammation activity in UC.
timeFrame: 2 years
Secondary outcomes:
measure: Good or Excellent interobserver and intraobserver agreement of pCLE diagnosis.
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: