Hybrid Endoscopic Stricturotomy Plus Balloon Dilation Versus Endoscopic Stricturotomy Alone for Short Strictures (<3 cm) in Crohn's Disease (The HEIST Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to Clinical Recurrence Within 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Endoscopic Stricturotomy (Procedure)
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.
干预措施: Endoscopic Stricturotomy (Procedure)
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.
干预措施: Endoscopic Balloon Dilation (Procedure)
结局指标
主要结局
Time to Clinical Recurrence Within 12 Months
时间窗: Up to 12 months post-procedure
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.
次要结局
- 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)
- Time to Stricture-Related Emergency Department Visit(Up to 12 months post-procedure)
- Adverse events(Up to 30 days post-procedure)