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.

NCT Number	NCT06958159
Lead Sponsor	Asian Institute of Gastroenterology, India
Conditions	Crohn Disease (CD)
Enrollment	40 participants
Start Date	2025-04-29
Primary Completion	2027-03-15 (estimated)
Study Completion	2027-05-15 (estimated)
Updated on ClinicalTrials.gov	2025-07-17