Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
Jessica K. Stewart, MD
40 participants
May 29, 2026
INTERVENTIONAL
Conditions
Summary
The purpose of this clinical trial is to compare two standard of care non-surgical treatments for hemorrhoidal bleeding: hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL). Directly comparing these two methods may help to clarify which treatment is better for controlling hemorrhoidal bleeding, reducing symptoms, and improving patients' quality of life. HAE is a standard minimally invasive procedure to put tiny particles or coils into the blood vessel that feeds a hemorrhoid to block the blood flow (embolization). This involves using a catheter inserted into an artery, using twilight (conscious) sedation. RBL is a standard procedure that involves using small rubber bands around the base of the hemorrhoids to cut off blood flow, causing it to shrink or shrivel.
Eligibility
Inclusion Criteria6
- Age ≥ 18 years and less than 90 years.
- Ability to provide written informed consent.
- Documented clinical history of chronic bleeding from internal hemorrhoids.
- Documented presence of Goligher grade II-III internal hemorrhoids.
- Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
- Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.
Exclusion Criteria10
- Moderate loss of kidney function, defined as estimated glomerular filtration rate of less than 45 mL/min.
- Significant arterial atherosclerosis that would limit selective angiography.
- Known alternative causes of GI bleeding.
- Allergy to iodinated contrast agents.
- Active infection or malignancy.
- Pregnancy.
- Active nicotine use within the last 12 months.
- Portal hypertension/rectal varices.
- Uncorrectable coagulopathy (INR > 2; Platelet count <100,000; PTT > 40 sec).
- 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.
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Interventions
Involves using a catheter inserted into an artery to put tiny particles or coils into the blood vessel that feeds the hemorrhoid to block the blood flow and shrink it.
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07559630