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Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS

ConditionsHemorrhoidal BleedingHemorrhoids, InternalHAERBL
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Hemorrhoidal Artery Embolization

    Device

    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.

  • Rubber Band Ligation

    Procedure/Surgery

    Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Hemorrhoidal Artery EmbolizationActive comparator 1 intervention
Group B: Rubber Band LigationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of procedures to control bleeding

To compare rates of control of bleeding from hemorrhoids, based on number of procedures needed for hemostasis, during prospective follow-up in patients with internal hemorrhoids undergoing arterial embolization versus rubber band ligation.

Time frame
6 months

Secondary outcomes

1

Complication rates

Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding).

Time frame
0-18 months
2

Time to control bleeding

Number of weeks to control bleeding post procedure

Time frame
0-18 months
3

Severe adverse events

Number of unscheduled ER visits or hospitalization for severe complications.

Time frame
0-18 months
4

Patient treatment satisfaction

Treatment satisfaction questionnaire

Time frame
0-18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessica K. Stewart, MD

Lead sponsor

University of California, Los Angeles

Sponsor institution

Terumo Medical Corporation

Collaborator

Source ClinicalTrials.gov
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