Hemorrhoidal Bleeding, Hemorrhoids, Internal, HAE, RBL
Conditions
Brief 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.
Detailed description
A single center, prospective, open-label, double arm, randomized trial to compare rates of control of bleeding from hemorrhoids, during prospective follow-up in patients with internal hemorrhoids undergoing hemorrhoidal artery embolization (HAE) versus rubber band ligation (RBL), and the number of procedures needed for hemostasis. Subjects will be considered enrolled in the study once they have provided informed consent. They will then be randomized to one of two arms after completion of the in-person screening visit. Subjects may proceed to the procedure visit after they have met all screening eligibility criteria. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will then be randomized to HAE or RBL in a 1:1 ratio. A total of 40 subjects will be enrolled in the study and followed for a duration of up to 18 months. All study subjects will undergo the initial procedures, consisting of a physical exam, vital signs, medical history, review of medications, laboratory blood evaluations, anascopy, and completion of completion of the hemorrhoidal disease symptom score (HDSS), the short health scale for hemorrhoidal disease (SHSHD), French bleeding score (FBS), and the visual analog scale (VAS) pain score questionnaires. After treatment follow-up visits will be at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks) post-procedure. At these visits, subjects will complete all or some of the following: completion of the HDSS, SHSHD, FBS, VAS, and treatment satisfaction questionnaires, review current medications, undergo a directed physical examination, complete laboratory evaluations, anoscopy, CTA abdomen/ pelvis imaging, and report any new adverse events (AEs). At 6 months, subjects will have the option to crossover because of continued bleeding. Subjects in the crossover group will undergo treatment with the other treatment modality, with follow up at 1 week (7 days ± 2 days), 1 month (4 weeks ± 1 week), retreatment (as needed), 2 months (8 weeks ± 2 weeks), 3 months (12 weeks ± 2 weeks), 6 months (24 weeks ± 2 weeks), and 12 months (52 weeks ± 4 weeks).
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.
PROCEDURERubber Band Ligation
Involves using a band to cut off blood flow to the hemorrhoid and shrink it.
Sponsors
Jessica K. Stewart, MD
Terumo Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A total of 40 subjects will be enrolled in the double-arm study, subjects will be randomized to HAE or RBL in a 1:1 ratio (20 assigned to HAE, 20 assigned to RBL). Subjects in the either arm will have the option to crossover to the other treatment modality if bleeding is not controlled by their 6-month follow-up time point. Subjects who crossover undergo the other treatment and undergo follow-up visits at \[1 week, 1 month, retreatment (if needed), 2 month, 3 month, 6 month, and 12 months\].
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of procedures to control bleeding | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rates | 0-18 months | Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding). |
| Time to control bleeding | 0-18 months | Number of weeks to control bleeding post procedure |
| Severe adverse events | 0-18 months | Number of unscheduled ER visits or hospitalization for severe complications. |
| Patient treatment satisfaction | 0-18 months | Treatment satisfaction questionnaire |
| Number of crossovers | 0-6 months | Number of subjects who crossover from rubber band ligation to HAE, or vice versa at 6-months post procedure due to continued bleeding. |
Countries
United States
Contacts
CONTACTAniket Joglekar, MD
CONTACTSaima Chaabane, PhD
PRINCIPAL_INVESTIGATORJessica Stewart, MD
University of California, Los Angeles
PRINCIPAL_INVESTIGATORDennis Jensen, MD
University of California, Los Angeles
Outcome results
None listed