Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Обзор

Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.

Подробное описание

Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. However, the initial data is limited due to variations in embolization techniques, few studies with prospective long-term follow-up, and studies focusing on patients with only severe symptoms. Further research is needed to understand the specific long-term effectiveness of different embolization materials in a population that more accurately reflects the large number of patients with hemorrhoidal disease who would likely benefit from HAE. The proposed research project includes 22 patients with symptomatic internal hemorrhoids. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.

Вмешательства

• Процедура Hemorrhoidal artery embolization
  Hemorrhoidal artery embolization (HAE) involves the deliberate blockage of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve symptoms related to internal hemorrhoids, especially bleeding.

Первичные конечные точки

• Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score [Срок оценки: From baseline to 12 months post procedure]

Вторичные конечные точки (8)

• Proportion of technically successful HAE procedures [Срок оценки: From baseline to 12 months post procedure]
• Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Hemorrhoid Disease Symptom Score (HDSS) [Срок оценки: From baseline to 12 months post procedure]
• Change in non-bleeding related symptoms of internal hemorrhoids as measured by the Short Health Scale-Hemorrhoidal Disease (SHSHD) [Срок оценки: From baseline to 12 months post procedure]
• Change in pain related to as measured by the Visual Analog Scale (VAS) [Срок оценки: From baseline to 12 months post procedure]
• Change in concomitant hemorrhoid medical therapy [Срок оценки: From baseline to 12 months post procedure]
• Level of patient satisfaction after HAE as determined by patient satisfaction questionnaire [Срок оценки: From baseline to 12 months post procedure]
• Proportion of patients requiring subsequent non-surgical internal hemorrhoid procedures [Срок оценки: From baseline to 12 months post procedure]
• Proportion of patients requiring surgical management of their internal hemorrhoids [Срок оценки: From baseline to 12 months post procedure]

Критерии участия

Критерии включения

• Age 18 to 90 years
• Ability to give written informed consent and to comply with the follow-up visits
• Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine
• Refusal of or contraindication to surgery
• Refusal of or contraindication to other minimally invasive hemorrhoid treatments
• Grade I to III hemorrhoids
• Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year
• Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization

Критерии исключения

• Asymptomatic patients
• Patients who ever had previous colorectal surgery
• Grade IV hemorrhoids
• Colorectal disease other than hemorrhoids that could result in bleeding
• Anatomic findings on CTA that would preclude successful embolization
• Contraindication to iodinated contrast
• Inability to give written informed consent
• Active infection or malignancy
• Recent (within 12 months) or active cigarette use
• History of inflammatory bowel disease
• Uncorrectable bleeding diathesis
• Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy
• No SRA or MRA supply to the CCR seen intra-procedural angiogram

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, Los Angeles — Los Angeles

Публикации

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• Margetis N. Pathophysiology of internal hemorrhoids. Ann Gastroenterol. 2019 May-Jun;32(3):264-272. doi: 10.20524/aog.2019.0355. Epub 2019 Jan 23. PMID 31040623
• Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abs PMID 38294832
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• Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014 Aug;109(8):1141-57; (Quiz) 1058. doi: 10.1038/ajg.2014.190. Epub 2014 Jul 15. PMID 25022811
• Makris GC, Thulasidasan N, Malietzis G, Kontovounisios C, Saibudeen A, Uberoi R, Diamantopoulos A, Sapoval M, Vidal V. Catheter-Directed Hemorrhoidal Dearterialization Technique for the Management of Hemorrhoids: A Meta-Analysis of the Clinical Evidence. J Vasc Interv Radiol. 2021 Aug;32(8):1119-1127. doi: 10.1016/j.jvir.2021.03.548. Epub 2021 May 7. PMID 33971251
• Vidal V, Louis G, Bartoli JM, Sielezneff I. Embolization of the hemorrhoidal arteries (the emborrhoid technique): a new concept and challenge for interventional radiology. Diagn Interv Imaging. 2014 Mar;95(3):307-15. doi: 10.1016/j.diii.2014.01.016. Epub 2014 Feb 28. PMID 24589187
• Panneau J, Mege D, Di Bisceglie M, Duclos J, Habert P, Bartoli A, Vidal V, Tradi F. Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques. Radiographics. 2022 Oct;42(6):1829-1844. doi: 10.1148/rg.220014. PMID 36190848

Идентификаторы

NCT: NCT07179601 · 25-0704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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