Actively Recruiting

All Genders
NCT04803916

Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study

Led by Shaare Zedek Medical Center · Updated on 2025-05-22

24

Participants Needed

1

Research Sites

413 weeks

Total Duration

On this page

Sponsors

S

Shaare Zedek Medical Center

Lead Sponsor

S

Sheffield Children's NHS Foundation Trust

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with Crohn's disease according to the latest international guidelines
  • Presence of strictured bowel (jejunal, ileal, colonic, or ileocecal valve), primary or anastomotic, with pre-stenotic dilatation over 2.5 cm on cross-sectional imaging
  • Evidence of pre-stenotic inflammation defined as wall thickness of at least 5 mm on imaging or SES-CD score of 3 or higher
  • Planned endoscopic balloon dilatation as part of clinical management
  • Stable Crohn's disease medications with no changes for at least 3 months prior, including immunomodulators, biologics, corticosteroids, or nutritional therapies
  • No planned treatment changes for 3 months after recruitment unless clinically necessary
Not Eligible

You will not qualify if you...

  • Patients deemed unsuitable for endoscopic balloon dilatation by their physician due to stricture or personal health reasons
  • Changes in Crohn's disease therapy (dose or type) within 3 months before planned endoscopic balloon dilatation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shaare Zedek

Jerusalem, Israel, 91031

Actively Recruiting

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Research Team

O

Oren Ledder, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study | DecenTrialz