NCT04803916 Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
| NCT ID | NCT04803916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shaare Zedek Medical Center |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2020-11-01 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2020-11-01 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Oren Ledder
PRINCIPAL INVESTIGATOR
Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
Frequently Asked Questions
Who can join the NCT04803916 clinical trial?
This trial is open to participants of all sexes, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04803916 currently recruiting?
Yes, NCT04803916 is actively recruiting participants. Contact the research team at orenl@szmc.org.il for enrollment information.
Where is the NCT04803916 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT04803916 clinical trial?
NCT04803916 is sponsored by Shaare Zedek Medical Center. The principal investigator is Oren Ledder at Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel. The trial plans to enroll 24 participants.