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.
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.
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
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.
Cohort
Prospective
Not listed
Endoscopic response
Decrease in SES-CD in the pre-stenotic region of ≥ 3 at 12 weeks compared to week 0
Endoscopic healing
Post-endoscopic balloon dilatation (EBD) mucosal healing in pre-stenotic region defined as regional SES-CD ≤ 1
Wall thickness
≥30% reduced intestinal wall thickness in pre-stenotic loop of bowel 12 weeks following successful EBD
Limberg score US
Decrease in Limberg grade of hyperemia in pre-stenotic region of ≥ 2
Luminal diameter
\>50% reduction of ratio of maximal upstream luminal diameter to minimal downstream luminal diameter
Click on the lead sponsor to view all of their trials.
Shaare Zedek Medical Center
Lead sponsor
Sheffield Children's NHS Foundation Trust
Collaborator
Bambino Gesù Hospital
Collaborator
University of Roma La Sapienza
Collaborator
Hopital Universitaire Robert-Debre
Collaborator
