Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease

Ntestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Medical Treatment of Intestinal Behcet's Disease: Prospective Observational Study

Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.

While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Behcet Disease

Detailed Description

Design: Prospective, single-center, cohort, observational study. Methods: The patients with intestinal Behcet's disease who have detectable bowel wall abnormality on baseline ileocolonoscopic examination, CT or MRE, and ultrasound are enrolled before starting the medical treatment. Before and until 26 weeks after the treatment, Disease Activity Index for Intestinal Behcet's disease, intestinal ultrasound, ileocolonoscopic examination, MRE, serum C-reactive protein and fecal calprotectin examinations are done.

Purpose: To investigate the accuracies of intestinal ultrasound in identifying endoscopic and clinical remissions. Additionally, to investigate the accuracies of MRE in identifying endoscopic and clinical remissions and responses. Further assessment may include cross-sectional correlation analysis between the different examination results and regression analysis to assess whether baseline examination results can predict the long-term clinical outcomes.

Sample size: 55 patients. The primary outcome of this study, the diagnostic accuracy of intestinal ultrasound in identifying endoscopic remission, has not been previous studied or reported in patients with intestinal Behcet's disease. Therefore, the investigators adopted the prospective study results published in Journal of Gastroenterology and Hepatology Open in 2020 which reported the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of intestinal ultrasound in diagnosing endoscopically active disease in Crohn disease (Sathananthan D et al. JGH Open. 2020;4(2):273-9). In that study, the sensitivity, specificity, PPV, and NPV were 91%, 83%, 91%, and 83%, respectively, in 17 patients with Crohn's disease. In the data, the accuracy must have been either 82% (14/17) or 88% (15/17). Therefore, the investigators expect the accuracy in this study to be approximately 85%. Using confidence intervals for one proportion with Score (Wilson) formula, the sample size was calculated to achieve a 95% confidence interval width of 20% for the primary outcome. This calculation resulted in a sample size of 49. Considering an expected dropout rate of 10%, the investigators aim to include a total number of 55 patients.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Hyun Kyung Yang; Phone Number: +82-2-2228-7400; Email: hkyang@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Hyun Kyung Yang; Phone Number: 82-2-2228-7400; Email: hkyang@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The investigators are enrolling ≥19 and <80-year-old patients who were diagnosed with intestinal Behcet's disease ≥3 months ago, whose disease activity is moderate or severe, and who visit Severance Hospital to be treated. The patients with bowel wall abnormality detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment are eligible. If there is no sonographic abnormality at week 0 that correlates the endoscopic and CT/MRE findings, the patient is not eligible. In addition, the patients who have complications not completely assessable with ultrasound and treating the complications is the treatment purpose; those who have enterocolitis attributable to the etiologies other than Behcet's disease; and those with morbidities that may affect the usual treatment of intestinal Behcet's disease are excluded.

Description

Inclusion Criteria:

- (1) The ≥19 and <80-year-old patients who diagnosed with intestinal Behcet's disease ≥3 months ago and whose disease activity is moderate or severe.

(2) Presence of abnormality in the bowel wall detected in the endoscopic examination and CT/MRE within the period ≤3 months before enrollment

Exclusion Criteria:

• (1) Duration of intestinal Behcet's disease <3 months (2) Presence of complication that is not completely assessble with ultrasound and treating the complication is the treatment purpose (3) Absence of ultrasound finding at week 0 that correlates the abnormal findings detected in the endoscopic examination and CT/MRE (4) Suspected ulcerative colitis, Crohn's disease, unclassificed colitis, ischemic colitis, radiation proctitis, diverticular disease, or microscopic colitis (5) Evidence of active tuberculosis on chest radiograph cf. Those who were treated for ≥3 weeks for latent tuberculosis can participate in the study.

  (6) Fecal stool positive for pathogenic bacteria or Clostiridum difficile toxin.

  (7) Positive for human immunodeficient virus infection (8) Patients with hepatitis B or C or hepatic dysfunction (9) Patients who did not consent to the study participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment	The accuracy is defined as (the number of the patients with both endoscopic and ultrasound remissions + number of the patients with both endoscopic and ultrasound non-remissions)/total number of the patients	26 weeks after initiation of the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment	The accuracy is defined as (the number of the patients with both clinical and ultrasound remissions + number of the patients with both clinical and ultrasound non-remissions)/total number of the patients.	26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment	The accuracy regarding endoscopic remission is defined as (the number of the patients with both endoscopic and magnetic resonance enterography remission + number of the patients with both endoscopic and magnetic resonance enterography non-remissions)/total number of the patients.; The accuracy regarding clinical remission is defined as (the number of the patients with both clinical and magnetic resonance enterography remission + number of the patients with both clinical and magnetic resonance enterography non-remissions)/total number of the patients.	26 weeks after initiation of the treatment.
Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment	The accuracy regarding endoscopic response is defined as (the number of the patients with both endoscopic and magnetic resonance enterography response + number of the patients with both endoscopic and magnetic resonance enterography non-response)/total number of the patients.; The accuracy regarding clinical response is defined as (the number of the patients with both clinical and magnetic resonance enterography response + number of the patients with both clinical and magnetic resonance enterography non-response)/total number of the patients.	26 weeks after initiation of the treatment.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 21, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: 4-2023-1730

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No