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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05636657

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Disease Inflammatory Bowel Diseases Crohn Disease Crohn Disease of 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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2025

Outcome Measures

Primary Outcome Measures

the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD) [At baseline]
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.
the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI) [At baseline]
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.