Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-04-30

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemorrhoid Hemorrhoid Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with bleeding grade II-III haemorrhoids

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

Haemorrhoid artery embolizsation (HAE)

Intervention Type PROCEDURE

Haemorrhoid artery embolization (HAE) is a minimally invasive procedure used to treat symptomatic haemorrhoids by reducing their blood supply. Under imaging guidance, typically fluoroscopy, a catheter is inserted through a small puncture in the groin or wrist and guided into the arteries that supply the haemorrhoidal tissue, known as the superior rectal arteries.

Once the target vessels are identified, embolization coils-tiny metal coils designed to block blood flow-are placed inside these arteries. The coils create a controlled blockage, decreasing blood flow to the haemorrhoids, which helps shrink the swollen tissue and reduce bleeding.

HAE is usually performed as an day-case procedure under local anaesthesia with mild sedation, and tends to result in less pain, quicker recovery, and lower complication rates compared to surgical approaches.

Interventions

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Haemorrhoid artery embolizsation (HAE)

Haemorrhoid artery embolization (HAE) is a minimally invasive procedure used to treat symptomatic haemorrhoids by reducing their blood supply. Under imaging guidance, typically fluoroscopy, a catheter is inserted through a small puncture in the groin or wrist and guided into the arteries that supply the haemorrhoidal tissue, known as the superior rectal arteries.

Once the target vessels are identified, embolization coils-tiny metal coils designed to block blood flow-are placed inside these arteries. The coils create a controlled blockage, decreasing blood flow to the haemorrhoids, which helps shrink the swollen tissue and reduce bleeding.

HAE is usually performed as an day-case procedure under local anaesthesia with mild sedation, and tends to result in less pain, quicker recovery, and lower complication rates compared to surgical approaches.

Intervention Type PROCEDURE

Other Intervention Names

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Embolization Coils

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No