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

December 1, 2022 updated by: Nanfang Hospital of Southern Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)
Time Frame: 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.
At baseline
the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
Time Frame: 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).
At baseline
the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)
Time Frame: 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.
at the third month of treatment
the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
Time Frame: 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).
at the third month of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xinmei Zhao, doctor, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2022-346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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