Malignant tumors and benign diseases of gynecology
Conditions
Interventions
Gold Standard:Pathologic diagnosis of biopsy specimens or after surgery.
Index test:Transvaginal finger-guided crude needle biopsy of pelvic masses with disposable biopsy needles
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old; 2. Clinical imaging indicates a suspicious pelvic mass, such as a cervical endogenous mass, where biopsy forceps cannot determine the nature of the initial diagnosis of cervical cancer. This includes advanced local staging of cervical cancer, post-radiotherapy paravaginal suspected residual lesions in gynecological oncology, recurrence of cervical or vaginal cancer at the vaginal stump where direct biopsy is not possible, and ovarian cancer involving the Douglas pouch. Cases unsuitable for initial cytoreductive surgery, where the nature of the lesion cannot be clarified through ascitic fluid analysis, or where the patient refuses surgical biopsy, yet histopathology is required to determine the nature of ovarian cancer. 3. Good coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times the upper limit of normal, or platelet count greater than 50 x 10?/L without transfusion in the last 14 days. 4. The mass is palpable during a gynecologic examination, and in cases of ovarian cancer with Douglas cavity implantation, a palpable mass greater than 2.5 cm in diameter is required. 5. Patients must be cooperative with the triple examination process and capable of signing an informed consent form independently. 6. Patients must be compliant and available for follow-up.
Exclusion criteria
Exclusion criteria: 1. Abnormal coagulation with a tendency to bleed. 2. Patients who are unable to cooperate with gynecological examinations or who are nulliparous. 3. Patients with suspected early-stage ovarian cancer where puncturing an adnexal mass may lead to upstaging of the disease. 4. In patients with suspected ovarian cancer, a mass can be palpated during a triple diagnosis, but the mass diameter does not exceed 2.5 cm. 5. Patients with suspected vascular tumors, tumors with significantly abnormal proliferative vasculature, or an uncontrolled risk of bleeding during biopsy. 6. A history or evidence of disease (e.g., poorly controlled hypertension, severe heart disease), abnormal treatment, or laboratory test results that may interfere with the trial's outcomes, or other potential risks as determined by the investigator that make the patient unsuitable for participation in this study. 7. Patients who are unable to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy; | — |
Countries
China
Contacts
Public ContactDan Li
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed