Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

N/ANot Yet RecruitingNCT07264413

Cardiovascular and Interventional Radiological Society of Europe250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Hemorrhoid Hemorrhoid Bleeding

Interventions

Haemorrhoid artery embolizsation (HAE)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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Haemorrhoidal bleeding

Evaluated using the French Bleeding Score.

Time frame: 12 months

Secondary Outcomes

Haemorrhoidal bleeding

Evaluation of haemorrhoidal bleeding at time points listed below compared to baseline using the French Bleeding Score.

Time frame: 1, 3 and 24 months

Patient-reported Pain using the Visual Analogue Scale

The 10 cm Visual Analogue Scale (VAS) is a patient-reported outcome measure used to assess the intensity of a symptom such as pain, discomfort, or bleeding. It consists of a straight, 10-centimeter horizontal line with two anchored endpoints: 0 cm = no symptom, and 10 cm = worst imaginable symptom. Participants mark a point on the line that best represents the severity of their symptom at the time of assessment. This will be measured at 1 day, 1- and 3-months after the treatment.

Time frame: 1 day, 1- and 3-months post treatment, compared to baseline

Patient-reported Pain measured by Analgesic intake

Analgesic intake refers to the use of any pain-relief medication taken to manage haemorrhoid-related discomfort after HAE. This includes over-the-counter or prescribed agents such as acetaminophen/paracetamol or NSAIDs. Participants will be recorded as having taken analgesics if they use any pain medication for haemorrhoid symptoms during the specified time frame.

Time frame: 1 day, 1- and 3-months post treatment

Frequency and severity of procedural complications and other adverse events

The severity of complications and procedure-related adverse events will be graded according to the Clavian Dindo classification system.

Time frame: Within 3 months after the HAE procedure

Functional recovery

Measured as the number of days until the patient is fit enough to return to work or other usual daily activities.

Time frame: From the procedure date until the patient returns to work or usual daily activities (Number of days)

Freedom from recurrence

Defined as the proportion of patients with cured or improved symptoms as described in the HubBle Trial.

Time frame: 1, 3, 12 and 24 months

Clinical appearance of haemorrhoids

Evaluated at proctoscopy at 12 months if done per SOC or following recurrence requiring further intervention.

Time frame: 12 months

Patient-reported symptoms

Evaluated using the Haemorrhoids Severity Score at the specified time points below compared to baseline.

Time frame: 3, 12 and 24 months

Patient-reported continence

Assessed using the Vaizey Incontinence Score at the specified time points below compared to baseline.

Time frame: 3 months

Patient-reported health-related quality-of-life

Measured by EuroQol Five-Dimension, Five-Level Questionnaire (EuroQol EQ-5D-5L) at the specified time points below compared to baseline. It is a standardized, participant-reported measure of health-related quality of life that assesses five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-each rated on five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to perform. Higher EQ-5D-5L index values indicate better overall health status, while lower scores reflect poorer health, greater symptom burden, or more functional impairment.

Time frame: 1 day, 1-, 3-, 12- and 24-months