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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)

S

Shanghai Jiao Tong University School of Medicine

Status

Completed

Conditions

Small Bowel Crohn's Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01555437
rjyyxhk0306

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

17 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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