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

NCT06958159 | Recruiting DMC

• 1 other identifier: AIG/IEC-BH&R 65/12.2024-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD)

Keywords

Endoscopic balloon dilation; Endoscopic stricturotomy; Crohn disease; re-intervention

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Recurrence Within 12 Months

  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.

  Up to 12 months post-procedure

Secondary Outcomes (7)

• Technical Success

  Day of procedure

• Clinical Response

  1 month post-procedure

• Time to Re-intervention

  Up to 12 months post-procedure

• Time to Intestinal Surgery

  Up to 12 months post-procedure

• Time to Stricture-Related Hospitalization

  Up to 12 months post-procedure

Study Arms (2)

Endoscopic Stricturotomy Alone

EXPERIMENTAL

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.

Procedure: Endoscopic Stricturotomy

Hybrid Endoscopic Stricturotomy Plus Balloon Dilation

EXPERIMENTAL

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.

Procedure: Endoscopic Stricturotomy; Procedure: Endoscopic Balloon Dilation

Interventions

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 Stricturotomy Alone; Hybrid Endoscopic Stricturotomy Plus Balloon Dilation

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.

Hybrid Endoscopic Stricturotomy Plus Balloon Dilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

Related Publications (1)

• Lan N, Shen B. Endoscopic Stricturotomy Versus Balloon Dilation in the Treatment of Anastomotic Strictures in Crohn's Disease. Inflamm Bowel Dis. 2018 Mar 19;24(4):897-907. doi: 10.1093/ibd/izx085.

  PMID: 29546384 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

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

CONTACT

+91-8945906823; partha0123456789@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, the outcomes assessors are blinded to group allocation. The individuals responsible for evaluating clinical outcomes-such as symptom recurrence, need for reintervention, hospitalization, emergency department visits, and surgical referral-are not involved in the endoscopic procedures and are unaware of which treatment (stricturotomy alone vs. hybrid therapy) the participant received. This masking is maintained throughout data collection and analysis to minimize bias in the assessment of primary and secondary outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)