NCT04803916Recruiting
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 stricturing of the bowel lumen, and even complete bowel obstruction. Stricturing CD is thought to be a major contributor to penetrating complications including abscesses and fistulae. Depending on the severity and clinical significance of fixed strictures, treatment options include either endoscopic balloon dilatation (EBD), or surgery with either resection or stricturoplasty recommended on a case-by-case basis. EBD has been shown to be a safe alternative to surgery in management of CD strictures. While the short- and medium-term clinical outcomes of EBD have been well described, less well studied is the impact of relieving Crohn's strictures on the inflammatory load proximal to the stricture. The restricted flow of fecal contents through a stricture creates a region of relative stasis in the bowel loops immediately proximal to the stricture, appreciated at times by pre-stenotic dilatation on cross-sectional imaging. This stasis fosters localized bacterial overgrowth and worsening dysbiosis in these bowel loops. The investigators hypothesize that improvement of fecal flow by way of successful balloon dilatation of a CD stricture, could independently reduce the inflammatory burden, not only in the stenotic segment but also in the proximal loop of bowel.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 31 Aug 2020
- Start date
- 1 Nov 2020
- Primary completion date
- Oct 2028
- Lead sponsor
- Shaare Zedek Medical Center
- Diseases
- Crohn's disease
- NCT number
- NCT04803916
What you commit to
- Study type: Observational
- Planned participants: 24
- From 1 Nov 2020 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in therapy (dose or type) in the 3 months prior to planned EBD
Other
- Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.