Status:
RECRUITING
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Sheffield Children's NHS Foundation Trust
Bambino Gesù Hospital
Conditions:
Crohn Disease
Eligibility:
All Genders
Brief Summary
As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stri...
Detailed Description
This prospective, observational study will include both pediatric and adult patients with stricturing CD on stable therapy who are planned to undergo EBD for management of a Crohn's stricture. Includ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients diagnosed with CD as per most recent international guidelines.
- Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation \>2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US))
- Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.
- Planned EBD as per clinical management.
- Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN).
- No planned treatment changes or additions over the 3 months following recruitment. The treating physician can change treatment at any time should the clinical need arise however the patient will be excluded from primary analysis
- Exclusion criteria:
- Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included
- Change in therapy (dose or type) in the 3 months prior to planned EBD
Exclusion
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04803916
Start Date
November 1 2020
End Date
October 1 2028
Last Update
May 22 2025
Active Locations (1)
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1
Shaare Zedek
Jerusalem, Israel, 91031