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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Asian Institute of Gastroenterology
RECRUITING
Hyderabad
Contact Information
Primary
Partha Pal, MD, DNB, MRCP (UK), FASGE
partha0123456789@gmail.com
+91-8945906823
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 40
Treatments
Experimental: Endoscopic Stricturotomy Alone
Participants in this arm will undergo endoscopic stricturotomy alone for the treatment of short (\<3 cm), fibrotic, symptomatic Crohn's disease strictures. The procedure will be performed using a needle knife or insulated-tip knife during colonoscopy, following a standardized protocol.
Experimental: Hybrid Endoscopic Stricturotomy Plus Balloon Dilation
Participants in this arm will undergo hybrid therapy consisting of endoscopic stricturotomy followed by controlled radial expansion balloon dilation of the stricture during the same session. The procedure is intended to enhance luminal patency and reduce the risk of recurrence.
Related Therapeutic Areas
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov