Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at Los Angeles 5368361, California 5332921
Dates
study started
study ends around
Principal Investigator
by Lucas Cusumano, MD

Description

Summary

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.

Details

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.

Keywords

Internal Hemorrhoids, HAE, Hemorrhoidal artery embolization

Eligibility

You can join if…

Open to people ages 18-90

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, Los Angeles
    Los Angeles 5368361 California 5332921 90095 United States

Lead Scientist at UCLA

  • Lucas Cusumano, MD
    HS Assistant Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 20 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07179601
Study Type
Interventional
Participants
Expecting 22 study participants
Last Updated