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

NCT04803916 | Recruiting

• 1 other identifier: Inflammation following EBD
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Crohn; Stricture; Endoscopic Balloon Dilatation

Outcome Measures

Primary Outcomes (1)

• Endoscopic response

  Decrease in SES-CD in the pre-stenotic region of ≥ 3 at 12 weeks compared to week 0

  12 weeks compared to week 0

Secondary Outcomes (12)

• Endoscopic healing

  week 12

• Wall thickness

  week 12 compared to week 0

• Limberg score US

  week 12 compared to week 0

• Luminal diameter

  week 12 compared to week 0

• Inflammed length

  week 12 compared to week 0

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• Sheffield Children's NHS Foundation Trust: collaborator
• Bambino Gesù Hospital: collaborator
• University of Roma La Sapienza: collaborator
• Hopital Universitaire Robert-Debre: collaborator

Study Sites (1)

Shaare Zedek

Jerusalem, 91031, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool specimen

MeSH Terms

Conditions

Crohn Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Oren Ledder

  Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Ledder, Dr.

CONTACT

+972-2-6666743; orenl@szmc.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: March 18, 2021
• Study Start: November 1, 2020
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

IL (1)