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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05636657
• Other study ID #: NFEC-2022-346
• Status: Not yet recruiting
• Start date: November 30, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xinmei Zhao, doctor
• Phone: 13268270713
• Email: xmzhao914[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn Disease of Small Intestine
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)	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.	At baseline
Primary	the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)	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).	At baseline
Primary	the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)	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.	at the third month of treatment
Primary	the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)	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).	at the third month of treatment