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

NCT04803916 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2025-05-22

No results posted yet for this study

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 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

  • Crohn Disease

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    collaborator OTHER

  • Bambino Gesù Hospital

    collaborator UNKNOWN

  • University of Roma La Sapienza

    collaborator OTHER

  • Hopital Universitaire Robert-Debre

    collaborator OTHER

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Oren Ledder · Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803916 on ClinicalTrials.gov