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

Small Bowel Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555437
• Other study ID #: rjyyxhk0306
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: November 18, 2013
• Start date: October 2008
• Est. completion date: February 2011

Study information

• Verified date: November 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Small Bowel Crohn's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weak, but significant, correlations were found between CESI and HBI (r=0.4, p<0.01).		2012.06	Yes
Primary	The correlation between CESI and CRP was moderate (r=0.58, p<0.01).		2012.07	Yes
Primary	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).		2012.08	Yes
Primary	Changes between baseline and follow-up CESI failed to correlate with the delta-HBI or delta-CRP (both, p>0.05).		2012.09	Yes