Evaluating imaging techniques for intestinal Behcet's disease treatment
Ntestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Medical Treatment of Intestinal Behcet's Disease: Prospective Observational Study
This study is testing if intestinal ultrasound and MRI can help doctors see how well treatments are working for people with moderate to severe intestinal Behcet's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06384391 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of intestinal ultrasound and magnetic resonance enterography (MRE) in monitoring treatment responses in patients with intestinal Behcet's disease. Patients aged 19 to 80 with moderate to severe disease will be enrolled and undergo various assessments, including disease activity indices and imaging techniques, before and after treatment over a 26-week period. The study seeks to determine the accuracy of these imaging methods in identifying clinical and endoscopic remissions, as well as their potential to predict long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 80 diagnosed with intestinal Behcet's disease for at least three months and exhibiting moderate to severe disease activity.
Not a fit: Patients with a disease duration of less than three months or those with complications not assessable by ultrasound may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of intestinal Behcet's disease by providing reliable imaging techniques to monitor treatment effectiveness.
How similar studies have performed: While the use of imaging techniques in inflammatory bowel disease has been explored, the specific application of intestinal ultrasound in intestinal Behcet's disease remains novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Yonsei University Health system, Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hyun Kyung Yang
- Email: hkyang@yuhs.ac
- Phone: +82-2-2228-7400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.