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

Yonsei University60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Symptomatic Uterine Fibroids

Interventions

uterine artery embolization using spherical gelfoamPROCEDURE

Uterine artery embolization is performed using spherical gelfoam. All other processes are same.

uterine artery embolization using tri-acryl gelatin microspherePROCEDURE

Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Outcomes

Primary Outcomes

Pain score (VAS score)

Maximum pain score measured during 24 hours after embolization

Time frame: up to 24 hours after embolization

Secondary Outcomes

C-reactive protein (mg/L)

inflammatory markers

Time frame: the day before and 24 hours after embolization

Tumor necrosis rate after embolization

technical success indicator

Time frame: 1 day and 3 months after embolization

Symptom severity questionnaire

clinical success indicator

Time frame: before and 3 months after embolization

White blood cell count (/µL)

inflammatory markers

Time frame: the day before and 24 hours after embolization

Neutrophil percentage (%)

inflammatory markers

Time frame: the day before and 24 hours after embolization

Cumulative fentanyl dose (µg)

Total amount of IV fentanyl administered

Time frame: within 24 hours after embolization

Use of rescue analgesics (%)

Necessity of additional rescue analgesics

Time frame: within 24 hours after embolization

Lymphocyte percentage (%)

Central Contacts

Man-Deuk Kim

CONTACT

82-10-8625-2197 mdkim@yuhs.ac

Data from ClinicalTrials.gov

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