Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Stricturotomy Alone for Short Crohn's Disease Strictures

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic 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.

Endoscopic 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.

Study 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

Primary outcome measure(s)

• Time to Clinical Recurrence Within 12 Months — Up to 12 months post-procedure
  Clinical recurrence is defined as a Crohn's Disease Obstruction Score (CDOS) \>2 following an initial clinical response. Initial response is defined as a ≥2-point reduction in CDOS or normalization to CDOS ≤2. Time to recurrence is measured from the date of the procedure to the first recurrence event. Participants without recurrence will be censored at their last follow-up or at 12 months.

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India

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