Hemorrhoidal artery embolization versus rubber band ligation for internal hemorrhoid bleeding

STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS

This trial will test whether hemorrhoidal artery embolization or rubber band ligation better stops bleeding and improves symptoms in adults with internal hemorrhoids.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: University of California, Los Angeles (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07559630 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–89 with chronic bleeding from Goligher grade II–III internal hemorrhoids who have failed conservative measures, can tolerate angiography and iodinated contrast (eGFR ≥45 mL/min), and can attend in-person follow-up at the UCLA site.

Not a fit: Patients unlikely to benefit include those with external-only hemorrhoids, portal hypertension or rectal varices, uncorrectable coagulopathy, significant arterial atherosclerosis preventing selective angiography, severe kidney impairment (eGFR <45 mL/min), allergy to iodinated contrast, active infection or malignancy, pregnancy, or recent nicotine use.

Why it matters

Potential benefit: If successful, the trial could identify the better first-line non-surgical option to reduce bleeding, decrease need for repeat procedures, and improve quality of life for patients with internal hemorrhoids.

How similar studies have performed: Rubber band ligation is a long-established treatment for internal hemorrhoids, while HAE has shown promising results in observational series but lacks large randomized comparative data.

Eligibility criteria

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 this trial is running

Los Angeles, California

• 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

Conditions: Hemorrhoidal Bleeding, Hemorrhoids, Internal, HAE, RBL