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

Official title

STRATOS: Single-center Randomized Controlled Trial of Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS

Overview

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

• Device Hemorrhoidal Artery Embolization
  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.
• Procedure Rubber Band Ligation
  Involves using a band to cut off blood flow to the hemorrhoid and shrink it.

Primary outcome measures

• Number of procedures to control bleeding [Time frame: 6 months]

Secondary outcome measures (5)

• Complication rates [Time frame: 0-18 months]
• Time to control bleeding [Time frame: 0-18 months]
• Severe adverse events [Time frame: 0-18 months]
• Patient treatment satisfaction [Time frame: 0-18 months]
• Number of crossovers [Time frame: 0-6 months]

Eligibility criteria

Inclusion criteria

• 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.
• Failed conservative treatment for bleeding hemorrhoids (e.g. fiber supplementation, topical ointments and creams, dietary modifications, stool softeners, warm baths).
• Able to comply with all treatments and protocol follow-up visits, in the opinion of the PI's.

Exclusion criteria

• 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.
• Active infection or malignancy.
• Pregnancy.
• Active nicotine use within the last 12 months.
• Portal hypertension/rectal varices.
• Uncorrectable coagulopathy (INR > 2; Platelet count <100,000; PTT > 40 sec).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Ronald Reagan UCLA Medical Center — Los Angeles

Publications

• 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. PMID 38876600
• 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. PMID 37430017
• 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. PMID 35551805
• 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. PMID 34456172
• 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. PMID 22563187
• 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. PMID 36190848
• 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. PMID 29601902
• 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. PMID 19513028

Identifiers

NCT: NCT07559630 · 25-2437

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗