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

NCT ID: NCT05636657

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinmei Zhao, doctor

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

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NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Xinmei Zhao, doctor

Role: CONTACT

13268270713

Facility Contacts

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Xinmei Zhao, Applicant

Role: primary

13268270713

Other Identifiers

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NFEC-2022-346

Identifier Type: -

Identifier Source: org_study_id

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