Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Internal Hemorrhoids; HAE

Treatments: Procedure: Hemorrhoidal artery embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT07179601

25-0704

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Hemorrhoidal artery embolization

Experimental group

Description:

Patients in this arm will undergo hemorrhoidal artery embolization (HAE) for treatment of symptomatic internal hemorrhoids

Treatment:

Procedure: Hemorrhoidal artery embolization