Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment (BRIGHT)

Cardiovascular and Interventional Radiological Society of Europe

Status: Begins enrollment in 1 month

Conditions: Hemorrhoid; Hemorrhoid Bleeding

Treatments: Procedure: Haemorrhoid artery embolizsation (HAE)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07264413

BRIGHT

Details and patient eligibility

About

BRIGHT is a Europe-wide study that will follow up to 250 adults with bleeding symptoms from haemmorhoids (Grade II-III categories). It aims to understand how well a minimally invasive procedure called haemorrhoid artery embolization (HAE) works in everyday clinical practice, which is a technique that blocks the blood vessels feeding the haemorrhoids. As this technique does not require major surgery, HAE offers several benefits such as less trauma, quicker recovery, and the use of only local anaesthesia.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients presenting bleeding Grade II-III haemorrhoids with French bleeding score ≥3 planned to be treated with HAE using embolization coils;
2. Patients competent and willing to give written informed consent.

Exclusion criteria

1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
2. Patients receiving HAE using a combination of coils and particles, particles only, or any other embolic agents;
3. Patients who have had previous surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE;
4. Patients with known perianal sepsis, inflammatory bowel disease, peri-anal fistula, colorectal malignancy or pre-existing sphincter injury resulting in incontinence;
5. Patients with an immunodeficiency;
6. Known severe atheromatous disease with occlusion of target vessels preventing embolization;
7. Absolute contraindication to contrast media;
8. ECOG performance status > 2;
9. Life expectancy < 12 months;
10. Patients with unstable angina;
11. Patients currently taking nicorandil.

Trial design

250 participants in 1 patient group

Adult patients with bleeding grade II-III haemorrhoids

Description:

Adult patients with bleeding grade II-III haemorrhoids planned to be treated with Haemorrhoid artery embolization (HAE) using embolization coils

Treatment:

Procedure: Haemorrhoid artery embolizsation (HAE)