Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment

Обзор

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.

Вмешательства

• Процедура 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 arte

Первичные конечные точки

• Haemorrhoidal bleeding [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Haemorrhoidal bleeding [Срок оценки: 1, 3 and 24 months]
• Patient-reported Pain using the Visual Analogue Scale [Срок оценки: 1 day, 1- and 3-months post treatment, compared to baseline]
• Patient-reported Pain measured by Analgesic intake [Срок оценки: 1 day, 1- and 3-months post treatment]
• Frequency and severity of procedural complications and other adverse events [Срок оценки: Within 3 months after the HAE procedure]
• Functional recovery [Срок оценки: From the procedure date until the patient returns to work or usual daily activities (Number of days)]
• Freedom from recurrence [Срок оценки: 1, 3, 12 and 24 months]
• Clinical appearance of haemorrhoids [Срок оценки: 12 months]
• Patient-reported symptoms [Срок оценки: 3, 12 and 24 months]
• Patient-reported continence [Срок оценки: 3 months]
• Patient-reported health-related quality-of-life [Срок оценки: 1 day, 1-, 3-, 12- and 24-months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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 PMID 27236344
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07264413 · BRIGHT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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