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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05636657
Enrollment
50
Registered
2022-12-05
Start date
2022-11-30
Completion date
2025-05-31
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Crohn Disease of Small Intestine, Digestive System Disease, Inflammatory Bowel Diseases

Keywords

Intestinal Color Ultrasound, Capsule Endoscopy, SUS-CD, CECDAI

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.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)At baselineThe 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 baselineThe 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).

Countries

China

Contacts

Primary ContactXinmei Zhao, doctor
xmzhao914@163.com13268270713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026