Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorJessica K. Stewart, MD
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hemorrhoidal Artery Embolization
- Rubber Band Ligation
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jessica K. Stewart, MD
Lead sponsor
University of California, Los Angeles
Sponsor institution
Terumo Medical Corporation
Collaborator
Source ClinicalTrials.gov