Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease

Not yet recruiting

• Conditions: Inflammatory Bowel Diseases; Digestive System Disease; Crohn Disease; Crohn Disease of Small Intestine

• Registration Number: NCT05636657
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and at the third month of treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.

Detailed Description

The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. Active lesions under intestinal color ultrasound were defined as SUS-CD ≥ 1, and active lesions under capsule endoscopy were defined as CECDAI ≥ 3.9. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and 3 months after treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-11-02
• Study Start: 2022-11-30
• Study First Submitted QC: 2022-12-01
• Last Update Submitted: 2022-12-01
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease;
• 2.At the time of inclusion, there were active lesions under color ultrasound or capsule endoscopy;
• 3.Voluntarily sign an informed consent form.

Exclusion Criteria

• 1.Patients with contraindications for capsule endoscopy;
• 2.In the judgment of the investigator, it is not suitable to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)	at the third month of treatment	The CECDAI was designed to evaluate three main parameters of Crohn's disease: inflammation (A), extent of disease (B), and stricture (C), in both the proximal and distal segments of the small bowel. The final score was calculated by adding the two segmental scores: CECDAI =(\[A1×B1\] +C1) +(\[A2×B2\] +C2).
the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)	at the third month of treatment	The Simple Ultrasound Score for Crohn's Disease \[SUS-CD\] is constituted by Bowel wall thickness (BWT) and colour Doppler. BWT：\<3 mm gets 0 score, 3 to 4.9 mm gets 1 score, 5 to 7.9 mm gets 2 scores, and intestinal wall thickness of ≥8 mm gets 3scores. Colour Doppler score：No or single vessel gets 0 score, 2-5 vessels per cm2 gets 1 score, \>5 vessels per cm2 gets 2 scores.

Trial Locations

Locations (1)

NanFang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China