Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 90 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 22 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Hemorrhoidal artery embolization

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

Procedure: Hemorrhoidal artery embolization

Hemorrhoidal artery embolization PROCEDURE

Hemorrhoidal artery embolization (HAE) involves the deliberate blockage 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 symptoms related to internal hemorrhoids, especially bleeding.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score