Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

NCT07264413 | Not Yet Recruiting

• 1 other identifier: BRIGHT
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemorrhoid; Hemorrhoid Bleeding

Keywords

Haemorrhoids; Grade II-III haemorrhoids; Symptomatic haemorrhoids; Hemorrhoidal bleeding; Haemorrhoidal disease; Haemorrhoid artery embolization; HAE; Artery embolization; Transarterial embolization; Minimally invasive; Embolization coils

Outcome Measures

Primary Outcomes (1)

• Haemorrhoidal bleeding

  Evaluated using the French Bleeding Score.

  12 months

Secondary Outcomes (10)

• Haemorrhoidal bleeding

  1, 3 and 24 months

• Patient-reported Pain using the Visual Analogue Scale

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

• Patient-reported Pain measured by Analgesic intake

  1 day, 1- and 3-months post treatment

• Frequency and severity of procedural complications and other adverse events

  Within 3 months after the HAE procedure

• Functional recovery

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

Study Arms (1)

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)

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.

Also known as: Embolization Coils

Adult patients with bleeding grade II-III haemorrhoids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.);
• Patients receiving HAE using a combination of coils and particles, particles only, or any other embolic agents;
• Patients who have had previous surgical haemorrhoidectomy at any time or other treatments for haemorrhoids within 1 year before the planned HAE;
• Patients with known perianal sepsis, inflammatory bowel disease, peri-anal fistula, colorectal malignancy or pre-existing sphincter injury resulting in incontinence;
• Patients with an immunodeficiency;
• Known severe atheromatous disease with occlusion of target vessels preventing embolization;
• Absolute contraindication to contrast media;
• ECOG performance status \> 2;
• Life expectancy \< 12 months;
• Patients with unstable angina;
• Patients currently taking nicorandil.

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead
• Medtronic: collaborator
• Cook Group Incorporated: collaborator

Related Publications (5)

• 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.

  PMID: 27236344 BACKGROUND

• 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.

  PMID: 9862829 BACKGROUND

• 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.

  PMID: 20035531 BACKGROUND

• 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.

  PMID: 32972102 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Claire Poulet, PhD

CONTACT

+41 79 385 16 78; bright@cirse.org

Dhwani S. Korde, PhD

CONTACT

+4367762942469; bright@cirse.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share