Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01555437
First received: March 13, 2012
Last updated: November 18, 2013
Last verified: November 2013

March 13, 2012
November 18, 2013
October 2008
February 2011   (final data collection date for primary outcome measure)
  • Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01). [ Time Frame: 2012.06 ] [ Designated as safety issue: Yes ]
  • The correlation between CESI and CRP was moderate (r=0.58, p<0.01). [ Time Frame: 2012.07 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01555437 on ClinicalTrials.gov Archive Site
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Assessment of Capsule Endoscopy Scoring Index (CESI), Harvey-Bradshaw Index (HBI) and Biological Markers in Small Bowel Crohn's Disease (SBCD)
Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease

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.

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.[7]

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.

Observational
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

serum of small bowel Crohn's disease patients

Probability Sample

All patients underwent CE examination (described below), and only those patients for whom complete CE examination (in which the capsule reached the cecum within the CE test time) was achieved were retained for study.

Small Bowel Crohn's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with known SBCD or newly diagnosed SBCD
  • those patients for whom complete CE examination (in which the capsule
  • reached the cecum within the CE test time) was achieved were retained for study

Exclusion Criteria:

  • incomplete CE examination
  • infectious enterocolitis
  • symptoms related to perianal penetrating disease
  • gastrointestinal cancer
  • ulcerative colitis
  • indeterminate colitis
  • history of extensive small bowel resection
  • known CD of the upper gastrointestinal tract or colon
  • intake of non-steroidal anti-inflammatory drugs (NSAIDs) (more than two tablets per week)
  • pregnancy
Both
17 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01555437
rjyyxhk0306
No
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
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Principal Investigator: Zhizheng Ge, MD. Ph.D RenJi Hospital
Shanghai Jiao Tong University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP