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

Recruiting now · Not applicable

Conditions studied: Crohn Disease (CD)

In brief

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.

Key facts

Study ID

NCT06958159

Run by

Asian Institute of Gastroenterology, India

People needed

40

Starts

2025-04-29

Expected to finish

2027-05-15

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Asian Institute of Gastroenterology — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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