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

RecruitingNAAges 18 Years - 65 YearsAllAsian Institute of Gastroenterology, India
NCT06958159 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 1

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📋 Eligibility rules (as published)
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.
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What it tests

  • Endoscopic Stricturotomy
  • Endoscopic Balloon Dilation
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Where

1 site
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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