Symptomatic uterine leimoyoma
Conditions
Interventions
Bilateral uterine arteries are embolized with gelatine sponge particles using microcatheter system inserted by Seldinger's technique. The embolization is terminated when the stasis of blood flow in th
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Symptomatic uterine leiomyomas confirmed by imaging studies with MRI or US. 2) Uncontrolled symptoms with medical therapies. 3) Premenopausal. 4) Adecuate cardiac, hepatic, renal, respiratory, and bone marrow functions. 5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 6) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnant, nursing, or desiring future pregnancy. 2) Active pelvic inflammatory disease. 3) Pelvic malignancy. 4) Previous hormonal therapy within 12 weeks. 5) Contraindication to MRI. 6) Contraindication to iodized contrast material. 7) Uncontrolled cardiac, respiratory, gastrointestinal, or nervous disorders. Uncontrolled diabetes, hypertension, or infection. 8) Adenomyosis confirmed with MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of symptoms, decrease of the volume of leiomyoma, changes in ovarian function, length of hospital stay. | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed