Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere

Study Overview
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Brief Summary
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This study is a prospective and randomized investigation planned to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in 60 patients with symptomatic fibroids.

Detailed Description
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This investigational study is designed to compare pain after uterine artery embolization using Gelatin microsphere or tris-acryl gelatin microsphere in patients with symptomatic fibroids. The primary end-points will be evaluated by assessing the maximum Visual Analogue Scale (VAS) score obtained for each time points within 24 hours after embolization. Secondary end-points consist of evaluating six items: 1) fentanyl and analgesic usage within 24 hours, 2) comparison of symptom severity score and health-related quality of life score, 3) comparison of postoperative inflammation, 4) assessment of tumor necrosis degree in Magnetic Resonance Imaging, 5) fluoroscopy and procedure time comparison, and 6) assessment of residual ovarian function before and after surgery (Serum AMH). This study included patients between the ages of 20 and less than 60 years of age who were diagnosed with uterine myoma and planned to undergo uterine artery embolization.

Official Title
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Comparison of Pain After Uterine Artery Embolization Using Gelatin Microsphere or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study

Conditions
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Uterine Myoma, Uterine Fibroid

Intervention / Treatment
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* Device: Gelatin microsphere (Nexsphere™)
* Device: Embosphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient aged between 20 and under 60 who decided to undergo uterine artery embolization for symptomatic uterine myoma. Exclusion Criteria: Bradycardia on electrocardiogram (< 45 bpm) Ventricular conduction abnormalities Liver failure Kidney failure Uncontrolled high blood pressure Obesity (BMI ≥ 30 ㎏/㎡) Patients who are allergic to drugs Patients who cannot read consent forms such as illiterate or foreigners Pregnant woman

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>The test group will be administered 300-500 ㎛ range of Gelatin microsphere (Nexsphere™). A suspension in which a contrast medium and physiological saline are mixed will be administered until the embolization is sufficiently achieved. | Device: Gelatin microsphere (Nexsphere™)<br>* Gelatin microsphere (Nexsphere™) is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications for gelatin microsphere are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.<br>|
| Active Comparator: Control group<br>The control group will be administered 500-700 ㎛ of Embospheres until sufficient embolization is achieved. | Device: Embosphere<br>* Tris-acryl gelatin microspheres (Embosphere Microspheres) are biocompatible and nonresorbable with cell adhesion properties for complete and durable mechanical occlusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity by numerical rating scale | 0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable | 0-24 hours after embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl and analgesic usage volume | Fentanyl and analgesic usage volume within 24 hours after embolization | 24 hours | 
| Symptom severity score | Comparison of symptom severity score before and 3 months after embolization Symptom was scored on a scale of 0-10, with 0 being no symptoms and 10 being the baseline, or initial symptoms. | 3 months | 
| Postoperative inflammation | Comparison of level or counts of C-Reactive Protein (CRP), leukocyte, neutrophil before and after embolization | 24 hours | 
| Tumor necrosis degree | Assessment of tumor necrosis degree in MR after embolization | 3 months | 
| Fluoroscopy and procedure time | Fluoroscopy and procedure time taken for embolization to achieved | procedure time | 
| Serum Anti-Mullerian Hormone (AMH) | Residual ovarian function before and after embolization | 3 months |