Status:
COMPLETED
Tracking the Natural Course of Silent Small Bowel Narrowing in Adults With Crohn's Disease
Lead Sponsor:
University Medical Center Zvezdara
Collaborating Sponsors:
Centre Hospitalo-Universitaire de Brabois, Vandoeuvre Les Nancy, France
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18-85 years
Brief Summary
Crohn's disease is a long-term condition that causes inflammation in the digestive tract. Over time, some people develop narrowings in the small intestine, called "strictures." These strictures can bl...
Detailed Description
SMALL BOWEL INCIDENTAL STRICTURES: EVALUATION OF NATURAL HISTORY IN ASYMPTOMATIC CROHN'S EVOLUTION (SILENCE STUDY) Crohn's disease (CD) is a progressive, chronic inflammatory disorder of the gastroin...
Eligibility Criteria
Inclusion
- • Patients who are asymptomatic, with no clinical signs of intestinal symptomatology (absence of abdominal pain, distension, nausea, vomiting, weight loss, diahorrea).
- Patients 18 years and older
- Small bowel stricture diagnosed incidentally either:
- at the time of initial Crohn's disease (CD) diagnosis (baseline visit), or
- in patients with a previously established diagnosis of mild CD who have maintained stable clinical, endoscopic and radiographic remission without previous stenosis for a minimum of 2 years prior to study entry.
- Diagnosis of Crohn's disease confirmed according to accepted clinical, endoscopic, radiologic, and/or histologic standards.
- Evidence of small bowel involvement by CD, either in the form of ileal, ileocolonic or jejunal disease. Presence of a small bowel stricture confirmed by MR enterography, intestinal ultrasound (IUS), or endoscopy.
- Only patients who have at least one year of longitudinal follow-up data in the medical record after the baseline/index evaluation will be included.
- Patients who went to colonoscopy due to asymptomatic iron deficiency anemia and/or positive fecal occult blood test or for routine CD follow up
- Minimum follow up period is one year, or event happened whichever comes first
Exclusion
- Presence of symptomatic strictures at the time of stenosis detection.
- Incomplete clinical data or follow-up
- Strictures attributable to neoplastic processes, prior radiation therapy, or congenital anomalies.
- Strictures are located exclusively in the colon.
- Clinical symptoms of active CD at the time the stricture was identified.
- History of prior small bowel or colonic resection.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07167745
Start Date
June 9 2025
End Date
August 30 2025
Last Update
September 11 2025
Active Locations (1)
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1
University Hospital Zvezdara
Belgrade, Serbia, Serbia, 11000