BIOPSAR study: ultrasound-guided pre-operative biopsy to assess histology of sarcoma-suspicious uterine tumors: a new study protocol.

BACKGROUND: The pre-operative differential diagnosis between a uterine leiomyoma and a sarcoma can be a challenge. Available diagnostic tools have difficulty distinguishing between the two pathologies. PRIMARY OBJECTIVE: Τo evaluate the possibility of a pre-operative pathological diagnosis of atypical uterine muscle tumors by vaginal ultrasound-guided biopsy (VUGB). STUDY HYPOTHESIS: Diagnostic performance of ultrasound-guided biopsy will be capable of differentiating a leiomyoma from a sarcoma with a sensitivity of >90%. TRIAL DESIGN: A prospective multi-center interventional study will be performed at 10 tertiary French centers. Vaginal ultrasound Doppler examination and pelvic magnetic resonance imaging will be performed before surgery. VUGB will then be performed by a specialist radiologist. The biopsy will be obtained by performing transvaginal ultrasound under local anesthesia with lidocaine using a 16G needle. At least 4-5 specimens will be obtained in order to provide a histopathological diagnosis. All patients included in the study will be operated by laparotomy. All patients included in the study will be followed up for the subsequent 3 years according to their pathological results. MAJOR INCLUSION/EXCLUSION CRITERIA: All patients >35 years old diagnosed with a suspicious uterine tumor will be included. PRIMARY ENDPOINT: Sensitivity of VUGB on pathological diagnosis. SAMPLE SIZE: Considering a sensitivity of 90% (H0) as acceptable and a sensitivity of 95% (H1) as excellent, a sample size of 250 evaluable patients will be necessary to achieve 80% statistical power with a 5% type 1 statistical error. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Accrual will be completed in December 2024 with results presented in December 2029. TRIAL REGISTRATION: Institutional Review Board (Ethic Committee of Paris Ile de France 6) no 2018-A02343-52.

Surgical restaging of patients with early­stage endometrial cancer with lymphovascular invasion does not significantly impact their survival outcomes.

Lymphovascular space invasion (LVSI) is considered to be a poor prognostic factor in endometrial cancer. However, management of patients with early-stage endometrial cancer with positive LVSI remains controversial. The main objective of the present study was to investigate whether surgical restaging of such patients has a significant effect on survival outcomes or may be otherwise omitted. A retrospective cohort study was conducted at the Gynaecologic Oncology Unit, Insitut Bergonie, Bordeaux, France for the period January 2003-December 2019. The present study included patients with definitive histopathological diagnosis of early-stage, grade 1-2 endometrial cancer with positive LVSI. Patients were divided into two groups: Those being restaged with pelvic and para-aortic lymphadenectomy (group 1) and those not restaged and receiving complementary therapy (group 2). The primary outcomes of the study were overall survival and progression-free survival. Epidemiological data, clinical and histopathological characteristics as well as complementary treatment received were also studied. Kaplan-Meier and Cox regression analyses were performed. Data from 30 patients were retrieved, of which restaging with lymphadenectomy was performed in 21 patients (group 1), while another 9 patients (group 2) were not restaged and received complementary therapy. Lymph node metastasis was observed in 23.8% of patients in group 1 (n=5). No significant difference was observed between groups 1 and 2 in terms of survival outcomes. The median overall survival was 91.31 months in group 1 and 90.61 months in group 2 [hazard ratio (HR), 0.71; 95% CI, 0.03-16.58; P=0.829]. The median disease-free survival was 87.95 months in group 1 and 81.52 months in group 2 (HR, 0.85; 95% CI, 0.12-5.91; P=0.869). In conclusion, restaging with lymphadenectomy did not alter prognosis of early-stage, LVSI-positive patients. As there was no clinical and therapeutic benefit, restaging with lymphadenectomy could be omitted in such patients.