RecruitingNot ApplicableNCT06958159

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)


Sponsor

Asian Institute of Gastroenterology, India

Enrollment

40 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two endoscopic (camera-based, non-surgical) techniques for widening tight, scarred sections of the bowel (strictures) in people with Crohn's disease. One technique combines a cutting procedure with balloon stretching, while the other uses the cutting procedure alone. Researchers want to see which keeps the stricture open longer. **You may be eligible if...** - You are an adult between 18 and 65 years old - You have been diagnosed with Crohn's disease - You have a fibrotic (scar tissue) bowel stricture that is less than 3 cm long - You have no more than two strictures - Your stricture is accessible via colonoscopy **You may NOT be eligible if...** - Your stricture is longer than 3 cm or located in a place the camera cannot reach - You have an active infection or abscess near the stricture - You have had prior surgery in that area of the bowel - You are pregnant or have significant bleeding disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic Stricturotomy

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. Radial incisions are initially made across the stricture, followed by circumferential cutting in non-ulcerated areas to relieve luminal narrowing. The goal is to achieve adequate stricture opening while minimizing the risk of perforation.

PROCEDUREEndoscopic Balloon Dilation

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 narrowing. The balloon is maintained at full inflation for 60 seconds to achieve controlled and uniform dilation of the stricture.


Locations(1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

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NCT06958159


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