Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)
|ClinicalTrials.gov Identifier: NCT01555437|
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : November 19, 2013
Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical presentation can vary considerably. Patients are frequently assessed by capsule endoscopy (CE), which enables direct visualization of small bowel mucosal abnormalities; however, the correlations between CE scoring index (CESI), biological markers, and disease activity indices remain undefined.
Methods: A prospective study was conducted between October 2008 and February 2011 on 58 established SBCD patients and suspected patients who received a definitive SBCD diagnosis during study. Patients underwent complete CE, and were scored according to the CESI (inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein (CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the patients underwent CE with scoring for CESI, HBI, and CRP.
|Condition or disease|
|Small Bowel Crohn's Disease|
Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The degree of disease involvement in each tertile was determined by assessing three parameters: villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of <135. Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.
HBI HBI was used to assess the clinical disease activity. Patients with HBI >4 were considered to have clinically active disease.
Blood analysis At the time of CE, patients provided a blood sample for measurement of hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men, 140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: <8 mg/L) were determined by routine laboratory tests.
|Study Type :||Observational|
|Actual Enrollment :||58 participants|
|Official Title:||Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
- Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01). [ Time Frame: 2012.06 ]
- The correlation between CESI and CRP was moderate (r=0.58, p<0.01). [ Time Frame: 2012.07 ]
- The median CRP value was significantly higher in patients with moderate-severe CESI, compared to the mild group (22.60±16.79 mg/L vs. 11.88±8.39 mg/L, p<0.01). [ Time Frame: 2012.08 ]
- Changes between baseline and follow-up CESI failed to correlate with the delta-HBI or delta-CRP (both, p>0.05). [ Time Frame: 2012.09 ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555437
|Principal Investigator:||Zhizheng Ge, MD. Ph.D||RenJi Hospital|