Hemorrhoidal artery embolization versus rubber band ligation for internal hemorrhoid bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label randomized trial will enroll 40 adults with Goligher grade II–III internal hemorrhoids and chronic bleeding who have failed conservative therapy and will randomize them 1:1 to hemorrhoidal artery embolization (HAE) or rubber band ligation (RBL). HAE is performed under conscious sedation using catheter-directed embolization of the feeding arteries, while RBL is performed by placing rubber bands at the hemorrhoid base; both are standard non-surgical treatments. Participants will have baseline exams and validated symptom and quality-of-life questionnaires and will be followed for up to 18 months with scheduled visits at 1 week, 1 month, 2 months, 3 months, 6 months and as-needed retreatment visits. Primary outcomes include control of bleeding and the number of procedures required for hemostasis, with secondary measures including pain scores and hemorrhoidal disease quality-of-life instruments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years and less than 90 years.
2. Ability to provide written informed consent.
3. Documented clinical history of chronic bleeding from internal hemorrhoids.
4. Documented presence of Goligher grade II-III internal hemorrhoids.
5. Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
6. Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.

Exclusion Criteria:

1. Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
2. Significant arterial atherosclerosis that would limit selective angiography.
3. Known alternative causes of GI bleeding.
4. Allergy to iodinated contrast agents.
5. Active infection or malignancy.
6. Pregnancy.
7. Active nicotine use within the last 12 months.
8. Portal hypertension/rectal varices.
9. Uncorrectable coagulopathy (INR \> 2; Platelet count \<100,000; PTT \> 40 sec).
10. Findings on baseline CTA that adversely affect treatment, based on PI's clinical judgment, including but not limited to stenosis, occlusion, or hypoplasia of the superior and/or middle rectal arteries.

Where it's running

• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Jessica Stewart, MD — University of California, Los Angeles
• Study coordinator: Aniket Joglekar, MD
• Email: ajoglekar@mednet.ucla.edu
• Phone: 310-948-8026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.