Clinical trial NCT05636657: Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease
Official title: Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Digestive System Disease
Inflammatory Bowel Diseases
Crohn Disease
Crohn Disease of Small Intestine
Keywords: Intestinal Color Ultrasound
Capsule Endoscopy
SUS-CD
CECDAI
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)
timeFrame: At baseline
measure: the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
timeFrame: At baseline
measure: the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)
timeFrame: at the third month of treatment
measure: the Capsule Endoscopy Crohn's Disease Activity Index(CECDAI)
timeFrame: at the third month of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xinmei Zhao, doctor
role: STUDY_CHAIR
References: