| Registry | NCT07754877 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 248 (Estimated) |
| Sponsor | Peking University Aerospace Center Hospital (Other) |
| Conditions | Uterine Fibroids (UF), Microwave Ablation, Ultrasound |
| Interventions | Microwave ablation combined with chemical ablation, Microwave ablation (Procedure) |
| Dates | start 2026-08-01 (estimated), primary completion 2028-08-30 (estimated), completion 2028-08-30 (estimated), first posted 2026-08-10, last updated 2026-08-10 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Uterine Fibroids (UF) All trials for Microwave Ablation All trials of Microwave ablation combined with chemical ablation All trials of Microwave ablation
Uterine fibroids are the most common benign tumors in women of reproductive age, with a prevalence of 20%-50%, often causing menorrhagia, anemia, pelvic pain, and pressure symptoms that markedly impair quality of life. Current treatments include pharmacological therapy (GnRH-a, mifepristone) - effective temporarily but with high recurrence after discontinuation; surgical myomectomy or hysterectomy - definitive yet invasive, with prolonged recovery and potential fertility compromise; and minimally invasive therapies such as uterine artery embolization (UAE), high-intensity focused ultrasound (HIFU), and microwave ablation (MWA), which are increasingly favored for their minimal invasiveness and rapid recovery.
MWA delivers thermal energy via a percutaneously inserted antenna under ultrasound guidance, inducing coagulative necrosis of fibroid tissue through temperatures exceeding 60°C. Advantages include minimal trauma (\~2 mm puncture), rapid recovery (discharge within 1-2 days), uterine preservation, and negligible ovarian impact. However, a key limitation is the heat sink effect: in hypervascular fibroids, flowing blood dissipates thermal energy, resulting in incomplete ablation, prolonged procedural time, and higher energy requirements - particularly challenging for fibroids >5 cm in diameter.
Chemical ablation involves intralesional injection of a sclerosing agent (e.g., lauromacrogol), which damages vascular endothelial cells, causing vascular occlusion, thrombosis, ischemic necrosis, and direct membrane disruption that accelerates apoptosis. Theoretically, pre-ablation chemical sclerotherapy may occlude feeding vessels, attenuate the heat sink effect, and enhance subsequent thermal ablation efficiency. Supporting this concept, an ex vivo bovine liver study demonstrated that pre-injection of 5 mL of 99.5% ethanol around the electrode prior to radiofrequency ablation produced a significantly larger ablation zone at equivalent energy levels compared with ablation alone. Small-sample clinical studies, including a prospective cohort from Shanghai Tenth People's Hospital, have preliminarily explored combined chemical ablation plus MWA for uterine fibroids, suggesting improved ablation rates and shorter procedural times, though findings require validation through high-quality randomized controlled trials.
Therefore, the investigators conducted this multicenter, prospective, randomized controlled trial to rigorously compare the safety (incidence and severity of adverse events) and efficacy (fibroid volume reduction rate, symptom improvement, quality-of-life outcomes) of MWA alone versus MWA combined with chemical ablation. This study aims to clarify the clinical value of the combined approach and provide high-quality, evidence-based data to guide the optimal selection of minimally invasive treatment strategies for uterine fibroids.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| control group | Experimental | Procedure: Microwave ablation | Microwave ablation of uterine fibroids was performed under real-time ultrasound guidance. |
| Experimental group | Experimental | Procedure: Microwave ablation combined with chemical ablation | Under real-time ultrasound guidance, chemical ablation of the uterine fibroid was performed first, followed by microwave ablation. |
Sex: Female
Inclusion Criteria: 1. A definitive diagnosis of uterine fibroids confirmed by magnetic resonance imaging (MRI) and ultrasonography, with the International Federation of Gynecology and Obstetrics (FIGO) classification 0-6; 2. At least one of the following symptoms: menorrhagia, secondary anemia, abdominal/pelvic pain, or compression symptoms; 3. Absence of perimenopausal signs; 4. A safe transabdominal puncture route accessible under imaging guidance. Exclusion Criteria: 1. Suspicion of malignancy on ultrasound or MRI that cannot be ruled out (e.g., uterine sarcoma; uterine fibroids coexisting with cervical, endometrial, or ovarian cancer; or other gynecological malignancies); 2. Uterine fibroids with coexisting adenomyosis; 3. Menstrual, gestational, or lactational period; 4. Uterine fibroids classified as FIGO type 7; 5. Known allergy to alcohol, lauromacrogol, or related sclerosing agents; 6. Absence of a safe percutaneous puncture route (e.g., lesion adherent to critical structures - bowel, bladder, or major vessels - that cannot be safely separated); 7. Uncontrolled acute pelvic inflammatory disease; 8. Significant hepatic, renal, or other major organ dysfunction; 9. Severe coagulopathy, defined as platelet count <50 × 10⁹/L, prothrombin time >25 s, or prothrombin activity <40%; 10. History of other malignancies; 11. Participation in another clinical trial within 1 month prior to informed consent; 12. Any other condition deemed by the investigator to render the subject unsuitable for participation in this trial.
| Facility | City | Country | Status |
|---|---|---|---|
| Aerospace center hospital | Beijing | China |