Comparing two endoscopic treatments for Crohn's disease strictures
Randomized Controlled Trial Comparing Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Strictures (< 3 cm) Related to Crohn's Disease (the BEST-CD Trial)
This study is testing whether endoscopic balloon dilation or endoscopic stricturotomy works better for treating blockages caused by Crohn's disease in patients with obstructive symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT05521867 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of endoscopic balloon dilation (EBD) and endoscopic stricturotomy (EST) in treating short strictures caused by Crohn's disease. Conducted at the Asian Institute of Gastroenterology in India, the study will include eligible patients with obstructive symptoms due to either de-novo or anastomotic strictures. Participants will be randomly assigned to receive either EBD or EST, and various clinical outcomes will be measured, including technical success, symptomatic improvement, and complications. The study seeks to provide a clearer understanding of which treatment modality is superior in managing Crohn's disease-related strictures.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of Crohn's disease experiencing obstructive symptoms due to short strictures.
Not a fit: Patients with long strictures, predominantly ulcerated strictures, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Crohn's disease, potentially reducing the need for surgery.
How similar studies have performed: While EBD has been established as a treatment, the comparative effectiveness of EBD and EST has not been previously tested in a randomized controlled manner, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Primary confirmed diagnosis of CD with obstructive symptoms 1. Gastro-duodenal and ileo-colonic strictures (both de novo and anastomotic strictures) 2. Short strictures (\<3 cm) 3. Fibrotic or mixed stricture (predominantly fibrotic) 4. Strictures treated with either EST or EBD. Exclusion Criteria: 1. No established diagnosis of CD; 2. No endoscopic therapy; and 3. A combination therapy of EST and EBD at the onset 4. Small bowel CD related stricture requiring enteroscopy guided dilation 5. Predominantly ulcerated strictures (mixed or pure ulcerated strictures) 6. Long strictures (\>3 cm) 7. Pediatric Patients (\<18 years) 8. Pregnant or lactating mother 9. Not willing to participate
Where this trial is running
Hyderabad, Telangana
- Asian lnstitute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Principal investigator: Partha Pal, MD, DNB — Asian lnstitute of Gastroenterology
- Study coordinator: Partha Pal, MD, DNB
- Email: partha1986@yahoo.com
- Phone: 8945906823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.