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

Официальное название

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

Обзор

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.

Подробное описание

The HEIST Study (Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures in Crohn's Disease) is a prospective, randomized controlled trial designed to compare two endoscopic treatment strategies for short, fibrotic strictures in patients with Crohn's disease. The trial specifically evaluates whether the addition of balloon dilation to endoscopic stricturotomy improves clinical outcomes compared to stricturotomy alone.

Eligible patients will have symptomatic, non-angulated strictures less than 3 centimeters in length, located in the colon or neo-terminal ileum. Participants will be randomly assigned during colonoscopy to receive either (1) endoscopic stricturotomy alone or (2) endoscopic stricturotomy followed by balloon dilation using a controlled radial expansion balloon (up to 18 mm diameter). Interventions will be performed using a therapeutic colonoscope and either a needle knife or insulated-tip knife, followed by balloon inflation if applicable.

All procedures will be carried out by experienced interventional endoscopists using a standardized protocol. Patients will be evaluated at baseline, immediately post-procedure, and at 1, 3, 6, and 12 months following the intervention. The follow-up includes clinical symptom scoring using the Crohn's Disease Obstructive Symptom Score, adverse event monitoring, quality of life assessment, and documentation of any further endoscopic or surgical intervention.

The primary outcome is the rate of clinical success at 12 months, defined as sustained symptom improvement without the need for repeat endoscopic or surgical intervention. Secondary outcomes include technical success, rate of complications (e.g., bleeding, perforation), time to re-intervention, and changes in quality of life metrics.

By evaluating these two commonly used endoscopic techniques in a randomized design with 12-month follow-up, the HEIST Study aims to provide evidence to optimize endoscopic treatment of short strictures in Crohn's disease and support treatment decisions in routine clinical practice.

Вмешательства

• Процедура Endoscopic Stricturotomy
  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 n
• Процедура Endoscopic Balloon Dilation
  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 uni

Первичные конечные точки

• Time to Clinical Recurrence Within 12 Months [Срок оценки: Up to 12 months post-procedure]

Вторичные конечные точки (7)

• Technical Success [Срок оценки: Day of procedure]
• Clinical Response [Срок оценки: 1 month post-procedure]
• Time to Re-intervention [Срок оценки: Up to 12 months post-procedure]
• Time to Intestinal Surgery [Срок оценки: Up to 12 months post-procedure]
• Time to Stricture-Related Hospitalization [Срок оценки: Up to 12 months post-procedure]
• Time to Stricture-Related Emergency Department Visit [Срок оценки: Up to 12 months post-procedure]
• Adverse events [Срок оценки: Up to 30 days post-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• Asian Institute of Gastroenterology — Hyderabad

Публикации

• 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

Идентификаторы

NCT: NCT06958159 · AIG/IEC-BH&R 65/12.2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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