Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Recruiting · NCT04803916 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shaare Zedek Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Shaare Zedek - Jerusalem, Israel