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

NCT01555437 | Completed

• 1 other identifier: rjyyxhk0306
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Small Bowel Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  2012.06

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

  2012.07

• 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

• Changes between baseline and follow-up CESI failed to correlate with the delta-HBI or delta-CRP (both, p>0.05).

  2012.09

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum of small bowel Crohn's disease patients

Study Officials

• Zhizheng Ge, MD. Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 19, 2013

Record last verified: 2013-11