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

Launched by SHAARE ZEDEK MEDICAL CENTER · Mar 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how a procedure called endoscopic balloon dilatation (EBD) can help patients with Crohn's disease who have narrowed areas in their intestines, known as strictures. These strictures can cause blockages and lead to further complications. Researchers want to see if relieving these strictures with EBD not only helps the affected area but also reduces inflammation in the parts of the bowel just before the stricture, which can get backed up and inflamed.

To take part in this trial, patients need to have a confirmed diagnosis of Crohn's disease and show signs of strictures in their intestines with some inflammation present. This means they should have a certain level of bowel wall thickening seen through imaging tests. Participants will undergo the EBD procedure, and their treatment for Crohn's disease must remain stable for three months before and after the procedure. It's important to know that if the treating doctor thinks EBD is unsuitable for a patient for specific reasons, that patient will not be able to join the study. This trial aims to better understand how treating strictures can improve overall bowel health for people with Crohn's disease.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 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
• Exclusion criteria:
• • 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