Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)

Overview

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.

Detailed description

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.

Interventions

• Procedure 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.

Primary outcome measures

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

Secondary outcome measures (8)

• Proportion of technically successful HAE procedures [Time frame: 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) [Time frame: 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) [Time frame: From baseline to 12 months post procedure]
• Change in pain related to as measured by the Visual Analog Scale (VAS) [Time frame: From baseline to 12 months post procedure]
• Change in concomitant hemorrhoid medical therapy [Time frame: From baseline to 12 months post procedure]
• Level of patient satisfaction after HAE as determined by patient satisfaction questionnaire [Time frame: From baseline to 12 months post procedure]
• Proportion of patients requiring subsequent non-surgical internal hemorrhoid procedures [Time frame: From baseline to 12 months post procedure]
• Proportion of patients requiring surgical management of their internal hemorrhoids [Time frame: From baseline to 12 months post procedure]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of California, Los Angeles — Los Angeles

Publications

• Ganz RA. The evaluation and treatment of hemorrhoids: a guide for the gastroenterologist. Clin Gastroenterol Hepatol. 2013 Jun;11(6):593-603. doi: 10.1016/j.cgh.2012.12.020. Epub 2013 Jan 16. No abstract available. PMID 23333220
• 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
• Cengiz TB, Gorgun E. Hemorrhoids: A range of treatments. Cleve Clin J Med. 2019 Sep;86(9):612-620. doi: 10.3949/ccjm.86a.18079. PMID 31498764
• 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

Identifiers

NCT: NCT07179601 · 25-0704

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗