Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555437
|Principal Investigator:||Zhizheng Ge, MD. Ph.D||RenJi Hospital|