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

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 Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoid; Hemorrhoid Bleeding
• Intervention / Treatment: Procedure: Haemorrhoid artery embolizsation (HAE)

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Claire Poulet, PhD; Phone Number: +41 79 385 16 78; Email: bright@cirse.org
• Study Contact Backup: Name: Dhwani S. Korde, PhD; Phone Number: +4367762942469; Email: bright@cirse.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bleeding grade II-III haemorrhoids (French Bleeding Score ≥3) planned to be treated with HAE coil-only embolization who fit the eligibility criteria

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: 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.; Other Names: Embolization Coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemorrhoidal bleeding	Evaluated using the French Bleeding Score.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemorrhoidal bleeding	Evaluation of haemorrhoidal bleeding at time points listed below compared to baseline using the French Bleeding Score.	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.	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.	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.	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.	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.	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.	12 months
Patient-reported symptoms	Evaluated using the Haemorrhoids Severity Score at the specified time points below compared to baseline.	3, 12 and 24 months
Patient-reported continence	Assessed using the Vaizey Incontinence Score at the specified time points below compared to baseline.	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.	1 day, 1-, 3-, 12- and 24-months

Collaborators and Investigators

• Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Collaborators: Medtronic; Cook Group Incorporated
• Investigators: Study Chair: Clare Bent, Dr, Royal Bournemouth Hospital, University Hospitals Dorset NHS Foundation Trust; Study Chair: Christoph A. Binkert, Prof. Dr. med., Medical Radiological Institute; Study Chair: Roberto Iezzi, Prof., Fondazione Policlinico Agostino Gemelli, IRCCS Catholic University; Study Chair: Vincent Vidal, Prof., Marseille University Hospital Timone

Publications and helpful links

General Publications

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
• Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
• Nystrom PO, Qvist N, Raahave D, Lindsey I, Mortensen N; Stapled or Open Pile Procedure (STOPP) trial study group. Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse. Br J Surg. 2010 Feb;97(2):167-76. doi: 10.1002/bjs.6804.
• Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.
• Fathallah N, Beaussier H, Chatellier G, Meyer J, Sapoval M, Moussa N, de Parades V. Proposal for a New Score: Hemorrhoidal Bleeding Score. Ann Coloproctol. 2021 Oct;37(5):311-317. doi: 10.3393/ac.2020.08.19. Epub 2020 Sep 18.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HAE; Haemorrhoids; Minimally invasive; Symptomatic haemorrhoids; Artery embolization; Grade II-III haemorrhoids; Hemorrhoidal bleeding; Haemorrhoidal disease; Haemorrhoid artery embolization; Transarterial embolization; Embolization coils
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: BRIGHT (Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No