Under construction – not a live service
Sign in
Taking people in IsraelNo phase

Studies bowel inflammation before narrowed Crohn's areas after balloon widening

Studies inflammation above narrowed bowel in Crohn's disease after balloon dilatation.

Key facts

Who runs it
Shaare Zedek Medical Center
Where
Jerusalem, IsraelSee the site
Trial code
Registry title
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Status
Recruiting
People taking part
24 people, planned
Started
1 Nov 2020
Expected to end
Oct 2028
Type of study
Observational
Record updated
22 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with Crohn's disease who have a narrowed bowel segment with swelling and inflammation just before it, and who are planned for balloon dilatation.

Sex
All sexes can join.
Disease stage
Crohn's disease with a narrowed bowel (jejunum, ileum, colon or ileocecal valve), either original or at a surgical join, with a widened loop above it of more than 2.5cm (1 in) diameter on imaging. Inflammation before the narrowing: wall thickness of 5mm or more on imaging, or pre-stenotic SES-CD of 3 or more.
Earlier treatment
No change in Crohn's medicines for 3 months before the procedure (immunomodulators, biologics, corticosteroids, or enteral nutrition). No treatment changes planned for 3 months after joining.

Main reasons for not taking part

  • People the treating doctor considers not appropriate for balloon dilatation
  • Change in Crohn's therapy (dose or type) in the 3 months before the planned dilatation

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Change in therapy (dose or type) in the 3 months prior to planned EBD
  • Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included

Where in Israel

  • Shaare ZedekJerusalem, IsraelContact: Oren Ledder, Dr.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Plain-language title
Studies bowel inflammation before narrowed Crohn's areas after balloon wideningGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 May 2025