Using Shear-Wave Elastography to Evaluate Intestinal Fibrosis in Crohn's Disease
Prospective Study to Evaluate the Role of Shear-Wave Elastography in Predicting the Degree of Intestinal Fibrosis in Patients With Crohn's Disease Who Are Candidates for Surgery - ElChir Study
This study is testing a new imaging technique to see if it can help doctors better understand and measure intestinal scarring in people with Crohn's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06056986 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of shear-wave elastography, a non-invasive imaging technique, in evaluating the degree of intestinal fibrosis in patients with Crohn's disease. By comparing elastographic parameters with histological findings from surgical specimens, the study seeks to improve the timing of surgical interventions for patients with fibrotic intestinal loops. Additionally, it will explore the relationship between clinical disease activity and elastographic measurements, as well as the concordance between different elastography methods and MRI parameters. The ultimate goal is to identify reliable elastographic cut-offs for predicting fibrosis severity.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with ileal or ileo-colonic Crohn's disease who are scheduled for elective intestinal resection within 30 days.
Not a fit: Patients with Crohn's disease without ileal involvement or those with other forms of inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for determining the need for surgery in Crohn's disease patients, potentially enhancing patient outcomes.
How similar studies have performed: Previous studies have shown promising results for shear-wave elastography in assessing intestinal fibrosis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of ileal or ileo-colonic Crohn's disease * patients scheduled for elective intestinal resection for Crohn's disease within 30 days from enrollment * affected intestinal segment detectable in B-mode ultrasound Exclusion Criteria: * diagnosis of IBD other than Crohn's disease * Crohn's disease without ileal involment * lack of visualization of affected intestinal tract (eg. obesity) * hearth failure * known allergy to ultrasound contrast agents * pregnancy * lactation
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Assunta Zocco
- Email: mariaassunta.zocco@policlinicogemelli.it
- Phone: 00393470597805
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.