Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Stricturotomy Alone for Short Crohn's Disease Strictures
Not applicable · Testing Endoscopic Stricturotomy and Endoscopic Balloon Dilation · 1 site · Asian Institute of Gastroenterology, India
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Endoscopic Stricturotomy (a procedure) and Endoscopic Balloon Dilation (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-04-29.
- Main results expected around 2027-03-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in India.
Main thing being measured
- Time to Clinical Recurrence Within 12 Months (Up to 12 months post-procedure)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Enrollment | 40 (estimated) |
| Start date | 2025-04-29 |
| Primary completion (est.) | 2027-03-15 |
| First posted | 2025-05-06 |
| Last updated | 2025-07-17 |
| Official title | Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study) |
| ClinicalTrials.gov ID | NCT06958159 |
Interventions
- Endoscopic Stricturotomy (Procedure)
Endoscopic stricturotomy is performed using either a needle knife or an insulated-tip (IT) knife (Olympus, Tokyo, Japan), selected based on the location and morphology of the stricture. Electrosurgical cutting is delivered using the Endo Cut I mode on an ERBE VIO 300D or VIO 3 electrosurgical unit (Erbe Elektromedizin, Germany), with standardized settings: Effect 3, Cut Duration 1, Cut Interval 3.… - Endoscopic Balloon Dilation (Procedure)
Endoscopic balloon dilation is performed using a Controlled Radial Expansion (CRE) balloon (Boston Scientific, USA). The size of the balloon is selected based on the estimated diameter of the stricture, presence or absence of ulceration, and the anatomical location. The balloon is gradually inflated under endoscopic visualization to a maximum diameter of 12-20 mm, tailored to the baseline luminal…
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad, Telangana | India | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.