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

NCT05636657 | Unknown

• 1 other identifier: NFEC-2022-346
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• the Simple Ultrasound Activity Score for Crohn's Disease (SUS-CD)

  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)

  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)

  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)

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease;
• Voluntarily sign an informed consent form.

You may not qualify if:

• Patients with contraindications for capsule endoscopy;
• In the judgment of the investigator, it is not suitable to participate in this study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Digestive System Diseases; Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Xinmei Zhao, doctor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Xinmei Zhao, doctor

CONTACT

13268270713; xmzhao914@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 5, 2022
• Study Start: November 30, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 5, 2022

Record last verified: 2022-10

Locations

CN (1)