Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07539727
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transabdominal Intestinal Ultrasound — DEVICE
    Transabdominal intestinal ultrasound using color Doppler will be performed to assess bowel wall thickness and vascularity in Crohn's disease patients who have achieved deep remission. This non-invasive imaging modality will be used to monitor patients over an 18-month period to evaluate its ability to predict clinical recurrence.

Study Details

Crohn's disease (CD) is a nonspecific chronic inflammatory condition characterized by a protracted course with alternating periods of relapse and remission. Even patients who achieve deep remission remain prone to recurrence and require long-term follow-up. While various monitoring methods are available, endoscopy plays a primary role in the management and diagnosis of CD; however, its relative invasiveness and the need for bowel preparation limit the feasibility of continuous monitoring. In contrast, transabdominal intestinal ultrasound offers advantages such as non-invasiveness, absence of radiation, good patient tolerance, and low cost, making it suitable for long-term monitoring. However, most studies have focused on exploring its concordance with disease activity and endoscopic findings, with only a limited number of studies examining its clinical significance for long-term prognosis. Therefore, we conducted a multicenter prospective study involving 18 months of follow-up in CD patients who achieved deep remission. Based on the follow-up results, patients were divided into relapse and non-relapse groups. Stratified analysis was performed according to the Montreal classification to compare color Doppler ultrasound parameters between the two groups and within each stratum, and to establish a predictive model.

Key Dates

First listed
Apr 20, 2026
Start date
Jan 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jan 1, 2029

Study Design

Enrollment
420 participants (estimated)

Arms

  • Arm: Relapse Group
    Patients with Crohn's disease who achieved deep remission at baseline but experienced clinical recurrence during the 18-month follow-up period. Their baseline ultrasound parameters will be analyzed to identify risk factors for recurrence.
  • Arm: Non-Relapse Group
    Patients with Crohn's disease who achieved deep remission at baseline and maintained remission without clinical recurrence throughout the 18-month follow-up period. This group serves as the control for comparing ultrasound parameters.

Primary Outcome Measure

Clinical Recurrence of Crohn's Disease [ Time Frame: 18 months after enrollment ]

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