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NCT Number: NCT06958159

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

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.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location status: Recruiting

Location contact

Duvvuru Nageshwar Reddy, MD, DM, MASGE, FACG, AGAF

CONTACT

[email protected]

+91-40-23378888

About this study

The HEIST Study (Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures in Crohn's Disease) is a prospective, randomized controlled trial designed to compare two endoscopic treatment strategies for short, fibrotic strictures in patients with Crohn's disease. The trial specifically evaluates whether the addition of balloon dilation to endoscopic stricturotomy improves clinical outcomes compared to stricturotomy alone.

Eligible patients will have symptomatic, non-angulated strictures less than 3 centimeters in length, located in the colon or neo-terminal ileum. Participants will be randomly assigned during colonoscopy to receive either (1) endoscopic stricturotomy alone or (2) endoscopic stricturotomy followed by balloon dilation using a controlled radial expansion balloon (up to 18 mm diameter). Interventions will be performed using a therapeutic colonoscope and either a needle knife or insulated-tip knife, followed by balloon inflation if applicable.

All procedures will be carried out by experienced interventional endoscopists using a standardized protocol. Patients will be evaluated at baseline, immediately post-procedure, and at 1, 3, 6, and 12 months following the intervention. The follow-up includes clinical symptom scoring using the Crohn's Disease Obstructive Symptom Score, adverse event monitoring, quality of life assessment, and documentation of any further endoscopic or surgical intervention.

The primary outcome is the rate of clinical success at 12 months, defined as sustained symptom improvement without the need for repeat endoscopic or surgical intervention. Secondary outcomes include technical success, rate of complications (e.g., bleeding, perforation), time to re-intervention, and changes in quality of life metrics.

By evaluating these two commonly used endoscopic techniques in a randomized design with 12-month follow-up, the HEIST Study aims to provide evidence to optimize endoscopic treatment of short strictures in Crohn's disease and support treatment decisions in routine clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

Primary outcomes

  1. Time to Clinical Recurrence Within 12 Months

    Time frame: 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.

Secondary outcomes

  1. Technical Success

    Time frame: Day of procedure

    Technical success is defined as the ability to pass a pediatric colonoscope beyond the treated stricture during the same session as the endoscopic procedure.

  2. Clinical Response

    Time frame: 1 month post-procedure

    Clinical response is defined as a reduction in CD Obstruction Score (CDOS) by ≥2 points from baseline, or normalization of the CDOS to ≤2, measured at 1 month after the intervention.

  3. Time to Re-intervention

    Time frame: Up to 12 months post-procedure

    Time (in days) from the index procedure to the first repeat endoscopic intervention (balloon dilation or stricturotomy or hybrid) for the same stricture. Participants without re-intervention will be censored at last follow-up or at 12 months

  4. Time to Intestinal Surgery

    Time frame: Up to 12 months post-procedure

    Time from the index endoscopic procedure to intestinal surgery related to the treated stricture. Participants who do not undergo surgery will be censored at the last follow-up or 12 months.

  5. Time to Stricture-Related Hospitalization

    Time frame: Up to 12 months post-procedure

    Time from the index procedure to first hospitalization caused by stricture-related complications or obstructive symptoms. Participants without hospitalization will be censored at last follow-up or 12 months.

  6. Time to Stricture-Related Emergency Department Visit

    Time frame: Up to 12 months post-procedure

    Time from the index endoscopic procedure to the first emergency department visit related to stricture-associated symptoms. Participants without an emergency visit will be censored at last follow-up or 12 months.

  7. Adverse events

    Time frame: Up to 30 days post-procedure

    Number and type of adverse events (e.g., bleeding, perforation, post-procedure pain, infection) occurring during or within 30 days of the endoscopic procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Partha Pal, MD, DNB, MRCP (UK), FASGE

CONTACT

[email protected]

+91-8945906823

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)

Acronym: HEIST

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 6, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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