Skip to main content
OpenTrials
Completed

NCT Number: NCT01555437

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Small Bowel Crohn's Disease

Age range

17 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01).

    Time frame: 2012.06

  2. The correlation between CESI and CRP was moderate (r=0.58, p<0.01).

    Time frame: 2012.07

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2012
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.