NCT06958159Recruiting
Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Stricturotomy Alone for Short Crohn's Disease Strictures
Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Crohn's disease is a chronic condition that can lead to inflammation and narrowing (strictures) of the intestine, causing symptoms like pain, bloating, and difficulty with bowel movements. These strictures are often treated with endoscopic procedures such as balloon dilation or stricturotomy to widen the narrowed segments and relieve symptoms. The HEIST Study is a randomized clinical trial designed to compare two endoscopic treatment strategies for short Crohn's disease-related strictures (less than 3 centimeters in length). One group will undergo endoscopic stricturotomy alone, while the other group will receive a combination of stricturotomy followed by balloon dilation (hybrid approach). The goal is to determine whether the hybrid approach improves long-term outcomes such as symptom relief, reduced need for repeat procedures, and avoidance of surgery. Patients will be followed for 12 months after treatment to assess durability of response, quality of life, and any complications or additional interventions needed. This study aims to provide high-quality evidence to guide endoscopic treatment of intestinal strictures in Crohn's disease and to help identify the most effective and safest approach for long-term symptom control.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 29 Apr 2025
- Primary completion date
- 15 Mar 2027
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Crohn's disease
- NCT number
- NCT06958159
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 29 Apr 2025 to the primary completion date, 15 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior endoscopic stricturotomy at the same stricture site.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.