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
  Purpose

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
Small Bowel Crohn's Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

serum of small bowel Crohn's disease patients


Enrollment: 58
Study Start Date: October 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555437

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Zhizheng Ge, MD. Ph.D SHANGHAI RENJI HOSPITAL
  More Information

No publications provided

Responsible Party: Zhizheng Ge, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01555437     History of Changes
Other Study ID Numbers: rjyyxhk0306
Study First Received: March 13, 2012
Last Updated: November 18, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
capsule endoscopy scoring index
Harvey-Bradshaw index
C-reactive protein
serum albumin
hemoglobin

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 22, 2014