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

Condition(s) studied

Investigational drug(s) / intervention(s)

Transabdominal Intestinal Ultrasound: 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 summary

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.

Eligibility

Primary outcome measure(s)

• Clinical Recurrence of Crohn's Disease — 18 months after enrollment
  The proportion of patients who experience clinical recurrence of Crohn's disease during the follow-up period. Clinical recurrence is defined by the return of active disease symptoms requiring a change in medical therapy or endoscopic confirmation of active inflammation.

Trial sites (1)

More Nanfang Hospital, Southern Medical University trials in China

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