ovarian mass
Conditions
Interventions
Gold Standard:Gold standard for surgical patients: histopathological diagnosis of postoperative resected specimens
Gold standard for non-surgical patients: > = 6 months of multimodal imaging follow-up (ultrasound/MRI once every 3 months) combined with comprehensive assessment of clinical outcomes (tumor markers, s
Malignancy: progression of lesions (volume increase >=10% or new metastases) with persistently elevated markers, or confirmation of malignancy by other routes (ascites cytology/metastases). Gold stand
Index test:Contrast-Enhanced Ultrasound-Guided Ovarian Biopsy Group (CEUS Group)
Contrast agent: Sulfur Hexafluoride Microbubbles for Injection (SonoVue®, Bracco)
Equipment: High-end ultrasound diagno
Sponsors
China-Japan Union Hospital of Jilin University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Imaging examination shows that there is a clear space-occupying lesion of the ovary; 2. There is a safe puncture and material collection path under the real-time guidance of ultrasound.
Exclusion criteria
Exclusion criteria: 1. Hemoglobin < = 8.0 g/dL; 2. Patients with obvious bleeding tendency, such as platelets less than 50 × 10^9 / L, and/or patients with coagulation dysfunction that is difficult to correct, and a history of oral anticoagulants within the past week; 3. Patients with serious diseases of heart, lung, brain and other important organs at the same time, unable to tolerate surgery; 4. Patients with lesions that cannot be clearly displayed by ultrasound due to excessive obesity or abdominal distention; 5. Patients who are difficult to cooperate with or refuse to be punctured due to various other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biopsy sampling success rate;Diagnostic accuracy;Negative predictive value;Sensitivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average number of punctures;Incidence of intraoperative and postoperative 24-hour complications; | — |
Countries
China
Contacts
Public ContactWang Hui
China-Japan Union Hospital of Jilin University
Outcome results
None listed