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| Name | Class |
|---|---|
| Terumo Medical Corporation | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhoidal Artery Embolization | Active Comparator | 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 | Active Comparator | Involves using a band to cut off blood flow to the hemorrhoid and shrink it. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates | Number of complications post procedure for each complication type (such as severe pain, thrombosis, or severe bleeding). | 0-18 months |
| Time to control bleeding | Number of weeks to control bleeding post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aniket Joglekar, MD | Contact | 310-948-8026 | ajoglekar@mednet.ucla.edu | |
| Saima Chaabane, PhD | Contact | 424-465-4482 | SChaabane@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Stewart, MD | University of California, Los Angeles | Principal Investigator |
| Dennis Jensen, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38876600 | Background | Yan Z, Gui Y, Liu C, Zhang X, Wen C, Olatunji OJ, Suttikhana I, Ashaolu TJ. Gastrointestinal digestion of food proteins: Anticancer, antihypertensive, anti-obesity, and immunomodulatory mechanisms of the derived peptides. Food Res Int. 2024 Aug;189:114573. doi: 10.1016/j.foodres.2024.114573. Epub 2024 May 28. | |
| 37430017 | Background |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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].
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| Rubber Band Ligation | Procedure | Involves using a band to cut off blood flow to the hemorrhoid and shrink it. |
|
| 0-18 months |
| Severe adverse events | Number of unscheduled ER visits or hospitalization for severe complications. | 0-18 months |
| Patient treatment satisfaction | Treatment satisfaction questionnaire | 0-18 months |
| Number of crossovers | Number of subjects who crossover from rubber band ligation to HAE, or vice versa at 6-months post procedure due to continued bleeding. | 0-6 months |
| Watanabe N, Hirose M, Hasegawa A, Mochida K, Ogura A, Inoue K. Derivation of embryonic stem cells from wild-derived mouse strains by nuclear transfer using peripheral blood cells. Sci Rep. 2023 Jul 10;13(1):11175. doi: 10.1038/s41598-023-38341-0. |
| 35551805 | Background | Douek M. Radiofrequency Ablation of Solid, Non-Functional Thyroid Nodules. Tech Vasc Interv Radiol. 2022 Jun;25(2):100821. doi: 10.1016/j.tvir.2022.100821. Epub 2022 Mar 15. No abstract available. |
| 34456172 | Background | Talaie R, Torkian P, Moghadam AD, Tradi F, Vidal V, Sapoval M, Golzarian J. Hemorrhoid embolization: A review of current evidences. Diagn Interv Imaging. 2022 Jan;103(1):3-11. doi: 10.1016/j.diii.2021.07.001. Epub 2021 Aug 27. |
| 22563187 | Background | Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World J Gastroenterol. 2012 May 7;18(17):2009-17. doi: 10.3748/wjg.v18.i17.2009. |
| 36190848 | Background | Panneau J, Mege D, Di Bisceglie M, Duclos J, Habert P, Bartoli A, Vidal V, Tradi F. Rectal Artery Embolization for Hemorrhoidal Disease: Anatomy, Evaluation, and Treatment Techniques. Radiographics. 2022 Oct;42(6):1829-1844. doi: 10.1148/rg.220014. |
| 29601902 | Background | Sandler RS, Peery AF. Rethinking What We Know About Hemorrhoids. Clin Gastroenterol Hepatol. 2019 Jan;17(1):8-15. doi: 10.1016/j.cgh.2018.03.020. Epub 2018 Mar 27. |
| 19513028 | Background | Jutabha R, Jensen DM, Chavalitdhamrong D. Randomized prospective study of endoscopic rubber band ligation compared with bipolar coagulation for chronically bleeding internal hemorrhoids. Am J Gastroenterol. 2009 Aug;104(8):2057-64. doi: 10.1038/ajg.2009.292. Epub 2009 Jun 9. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |