Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score
研究概览
简要总结
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.
详细描述
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. However, the initial data is limited due to variations in embolization techniques, few studies with prospective long-term follow-up, and studies focusing on patients with only severe symptoms. Further research is needed to understand the specific long-term effectiveness of different embolization materials in a population that more accurately reflects the large number of patients with hemorrhoidal disease who would likely benefit from HAE. The proposed research project includes 22 patients with symptomatic internal hemorrhoids. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 90 years
- •Ability to give written informed consent and to comply with the follow-up visits
- •Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
- •Refusal of or contraindication to surgery
- •Refusal of or contraindication to other minimally invasive hemorrhoid treatments
- •Grade I to III hemorrhoids
- •Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year
- •Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization
排除标准
- •Asymptomatic patients
- •Patients who ever had previous colorectal surgery
- •Grade IV hemorrhoids
- •Colorectal disease other than hemorrhoids that could result in bleeding
- •Anatomic findings on CTA that would preclude successful embolization
- •Contraindication to iodinated contrast
- •Inability to give written informed consent
- •Active infection or malignancy
- •Recent (within 12 months) or active cigarette use
- •History of inflammatory bowel disease
- •Uncorrectable bleeding diathesis
- •Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy
- •No SRA or MRA supply to the CCR seen intra-procedural angiogram
研究组 & 干预措施
Hemorrhoidal artery embolization
Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids
干预措施: Hemorrhoidal artery embolization (Procedure)
结局指标
主要结局
Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score
时间窗: From baseline to 12 months post procedure
次要结局
- Proportion of technically successful HAE procedures(From baseline to 12 months post procedure)
- Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Hemorrhoid Disease Symptom Score (HDSS)(From baseline to 12 months post procedure)
- Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Short Health Scale-Hemorrhoidal Disease (SHSHD)(From baseline to 12 months post procedure)
- Change in pain related to as measured by the Visual Analog Scale (VAS)(From baseline to 12 months post procedure)
- Change in concomitant hemorrhoid medical therapy(From baseline to 12 months post procedure)
- Level of patient satisfaction after HAE as determined by patient satisfaction questionnaire(From baseline to 12 months post procedure)
- Proportion of patients requiring subsequent non-surgical internal hemorrhoid procedures(From baseline to 12 months post procedure)
- Proportion of patients requiring surgical management of their internal hemorrhoids(From baseline to 12 months post procedure)
研究者
Lucas R. Cusumano, MD
Interventional Radiologist, Assistant Clinical Professor
University of California, Los Angeles