Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids

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

The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Uterine Fibroids
• Intervention / Treatment: Procedure: uterine artery embolization using spherical gelfoam; Procedure: uterine artery embolization using tri-acryl gelatin microsphere

Detailed Description

Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man-Deuk Kim; Phone Number: 82-10-8625-2197; Email: mdkim@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Contact: Man-Deuk Kim; Phone Number: 82-10-8625-2197; Email: mdkim@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria:

1. Bradycardia (<45 bpm)
2. Conduction abnormalities
3. Liver failure
4. renal failure
5. Uncontrolled hypertension
6. High grade obesity (BMI ≥ 30 kg/m2)
7. Drug allergy
8. Illiteracy
9. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spherical gelfoam; Patients who receive uterine artery embolization for symptomatic fibroids	Procedure: uterine artery embolization using spherical gelfoam; Uterine artery embolization is performed using spherical gelfoam. All other processes are same.
Active Comparator: Microsphere; Patients who receive uterine artery embolization for symptomatic fibroids	Procedure: uterine artery embolization using tri-acryl gelatin microsphere; Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (VAS score)	Maximum pain score measured during 24 hours after embolization	up to 24 hours after embolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein (mg/L)	inflammatory markers	the day before and 24 hours after embolization
Tumor necrosis rate after embolization	technical success indicator	1 day and 3 months after embolization
Symptom severity questionnaire	clinical success indicator	before and 3 months after embolization
White blood cell count (/µL)	inflammatory markers	the day before and 24 hours after embolization
Neutrophil percentage (%)	inflammatory markers	the day before and 24 hours after embolization
Cumulative fentanyl dose (µg)	Total amount of IV fentanyl administered	within 24 hours after embolization
Use of rescue analgesics (%)	Necessity of additional rescue analgesics	within 24 hours after embolization
Lymphocyte percentage (%)	Inflammatory marker	the day before and 24 hours after embolization

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Man-Deuk Kim, Department of Radiology, Severance hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Pain; Fibroid; Embolization
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Hemostatics; Coagulants; Gelatin Sponge, Absorbable
• Other Study ID Numbers: 4-2021-0467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No