Hybrid stricturotomy plus balloon dilation versus stricturotomy alone for short Crohn's strictures
Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)
This study will test whether adding balloon dilation to endoscopic stricturotomy helps adults with short Crohn's strictures have fewer symptoms and need fewer repeat procedures or surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06958159 on ClinicalTrials.gov |
What this trial studies
The HEIST trial randomly assigns adults with symptomatic, non-angulated Crohn's strictures under 3 cm in the colon or neo-terminal ileum to receive either endoscopic stricturotomy alone or stricturotomy followed by controlled balloon dilation. Procedures are performed during colonoscopy by experienced interventional endoscopists using standardized techniques and devices. Participants are followed at 1, 3, 6, and 12 months with symptom scoring, quality-of-life measures, adverse event monitoring, and documentation of any further endoscopic or surgical interventions. The primary focus is on durability of symptom relief and need for re-intervention over 12 months.
Who should consider this trial
Good fit: Adults 18–65 with symptomatic, non-angulated fibrotic or mixed Crohn's strictures shorter than 3 cm (up to two accessible strictures) in the colon or neo-terminal ileum are the intended participants.
Not a fit: Patients with predominantly inflammatory or ulcerated strictures, strictures longer than 3 cm, inaccessible locations, pregnancy, three or more strictures, or prior stricturotomy at the same site are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the hybrid approach could reduce the need for repeat endoscopic procedures and surgery while improving symptom control and quality of life for patients with short fibrotic strictures.
How similar studies have performed: Endoscopic stricturotomy and balloon dilation are established treatments for short Crohn's strictures, but randomized data directly comparing the combined hybrid approach to stricturotomy alone are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 65 years. * Diagnosed Crohn's disease based on clinical, endoscopic, histologic, or radiologic criteria. * Presence of fibrotic or mixed strictures measuring less than 3 cm in length. * A maximum of two strictures per patient. * Strictures located in endoscopically accessible sites Exclusion Criteria: * Predominantly ulcerated or active inflammatory strictures. * Strictures longer than 3 cm. * Strictures not accessible via standard colonoscopy. * Pregnancy. * Three or more strictures identified in a single patient. * Prior endoscopic stricturotomy at the same stricture site.
Where this trial is running
Hyderabad, Telangana
- Asian Institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: Partha Pal, MD, DNB, MRCP (UK), FASGE
- Email: partha0123456789@gmail.com
- Phone: +91-8945906823
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.