Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques.
Julien Panneau, Diane Mege, Mathieu Di Bisceglie...
https://pubmed.ncbi.nlm.nih.gov/36190848/Actively Recruiting
Led by Jessica K. Stewart, MD · Updated on 2026-07-10
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are comparing two standard non-surgical treatments for bleeding from internal hemorrhoids hemorrhoidal artery embolization HAE and rubber band ligation RBL. This study aims to determine which treatment better controls bleeding, reduces symptoms, and improves quality of life for patients with chronic internal hemorrhoid bleeding. The trial is a prospective, open-label, randomized study involving 40 subjects followed for up to 18 months. Participants will be randomly assigned to receive either HAE, a minimally invasive procedure where tiny particles or coils are placed via catheter into the artery feeding the hemorrhoid to block blood flow, or RBL, which uses small rubber bands to cut off blood supply to the hemorrhoids causing them to shrink. After initial treatment, follow-up visits will occur at various intervals up to 12 months. If bleeding continues at 6 months, participants have the option to switch to the other treatment and undergo similar follow-up. Throughout the study, participants will undergo physical exams, vital sign checks, blood tests, anoscopy, and complete questionnaires assessing hemorrhoidal symptoms, bleeding, pain, and treatment satisfaction. Imaging with CTA of the abdomen and pelvis will be performed during follow-up. Researchers will monitor the number of procedures needed to control bleeding, complication rates, time to bleeding control, adverse events, and patient satisfaction. The total study duration for each participant may be up to 18 months.
CONDITIONS
Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
A
Aniket Joglekar, MD
S
Saima Chaabane, PhD
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Jessica K. Stewart, MD
Lead Sponsor
Terumo Medical Corporation
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Hemorrhoidal Artery Embolization | Rubber Band Ligation |
|---|---|---|
| What it is | Minimally invasive, catheter-based procedure using embolization coils or particles to block hemorrhoidal arteries, reducing blood flow to shrink hemorrhoids. | Procedure placing a tight rubber band at the base of internal hemorrhoids to cut off blood supply and cause them to shrink and detach. |
| Role in Trial | Active investigational procedure applied as one assigned condition in a crossover trial to control hemorrhoidal bleeding. | Active comparator procedure provided to all participants in a separate crossover period. |
| Primary use | Treatment for chronic bleeding due to internal hemorrhoids, especially after failure of conservative therapy. | Standard procedure to treat internal hemorrhoids with persistent bleeding; commonly used when conservative measures fail. |
| How it is given or performed | Performed by interventional radiologists using arterial access, selective angiography, and placement of embolization materials targeting hemorrhoidal vessels. | Done by gastroenterologists or surgeons with endoscopic visualization, placing a rubber band around the base of the hemorrhoid. |
| Evidence status | Growing evidence from observational studies and recent reviews suggests embolization may reduce bleeding and symptoms in internal hemorrhoids, but randomized comparative data remain limited. | Well-supported by clinical trials and reviews as an effective treatment for bleeding internal hemorrhoids; durable results and safety profile established. |
| Important limitations | Embolization technique relies on operator expertise and imaging; longer-term safety and outcome data are limited, and anatomical variations may complicate success. | Band ligation may have post-procedure pain, bleeding, and risk of recurrence; not suitable for external hemorrhoids and may not work as well in very large grades. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 in-person screening visit
Duration - Initial procedure with follow-up up to 12 months
Participants receive either hemorrhoidal artery embolization or rubber band ligation to treat bleeding hemorrhoids.
Multiple follow-up visits at 1 week, 1 month, 2, 3, 6, and 12 months post-procedure
Duration - Up to 12 months post-crossover procedure
Participants with continued bleeding at 6 months may switch to the other treatment and have similar follow-up visits.
Follow-up visits at 1 week, 1 month, 2, 3, 6, and 12 months after crossover
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Terumo Medical Corporation
Collaborating Sponsor