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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Small Bowel Crohn's Disease

Keywords

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capsule endoscopy scoring index Harvey-Bradshaw index C-reactive protein serum albumin hemoglobin

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhizheng Ge

Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhizheng Ge, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Other Identifiers

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rjyyxhk0306

Identifier Type: -

Identifier Source: org_study_id