Background Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking. Primary Objectives The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes. Study Hypothesis We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy. Trial Design This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy. Major Inclusion and Exclusion Criteria Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy. Primary Endpoint(s) The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer. Sample size 178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027. Trial Registration Number NCT03366051.
27 August 2021 in American Journal of Obstetrics and Gynecology
Our aim in the present study was to evaluate surgical outcomes and complications of pelvic exenteration in the treatment of gynecologic malignancy and to compare surgery-related complications associated with different types of exenteration. We performed a retrospective analysis of patients who underwent pelvic exenteration for the treatment of gynecologic cancer between January 2008 and August 2011. Patients were divided into two groups for comparison: total pelvic exenteration (TPE) and nontotal pelvic exenteration (NTE, including anterior pelvic exenteration (APE) posterior pelvic exenteration (PPE)). Outcomes are reported according to the modified Clavien-Dindo Classification of Surgical Complications. Twenty-eight patients were included in the analysis. Eighteen had cervical cancer (64.3%). The prevalence of stage IIIB cervical cancer was 55%. Primary treatment with radiotherapy was performed in 53.3% of patients. Fifty percent of patients underwent TPE, 25% had APE and 25% underwent PPE. Patients who underwent TPE had worse outcomes, with a mean operative time of 367 minutes, use of blood transfusion in 93% of patients, ICU stay of 4.3 days and total hospital stay of 9.4 days. The overall mortality rate was 14.3%, and the surgical site infection rate was 25%. In the TPE group, 78.6% of patients experienced surgical complications. One-fourth of the total patient sample required reoperation, and the leading cause was urinary fistula (57.1%). Urinary leakage occurred in 22.7% of urinary reconstruction patients. Wet colostomy was the most common form of reconstruction with 10% of leakage. Postoperative urinary and infectious complications accounted for 75% of all causes of morbidity and mortality after pelvic exenteration. TPE is a more complex and morbid procedure than NTE.
28 October 2023 in International Journal of Gynecological Cancer
Objective To evaluate the feasibility of uterine transposition as a method of preserving fertility and ovarian function after pelvic radiation. Methods This prospective multicenter observational study included patients with non-gynecologic pelvic cancers who underwent pelvic radiation as part of their cancer treatment between June 2017 and June 2019. For inclusion in the study, patients were required to have normal menstrual cycles and hormone levels (follicle-stimulating hormone, luteinizing hormone, and estrogen) before treatment. Uterine transposition to the upper abdomen was performed prior to irradiation. Clinical examinations and Doppler ultrasonography were used to evaluate the gonadal vasculature post-surgery. The uterus was repositioned into the pelvis 2–4 weeks after radiation therapy or at the time of rectosigmoid resection in patients with rectal cancer who had undergone neoadjuvant treatment. Cancer treatment and follow-up were performed according to standard guidelines. Results Eight patients (seven with rectal cancer and one with pelvic liposarcoma) underwent uterine transposition at a median age of 30.5 years (range 19–37). The uterus was successfully preserved in six patients, accompanied by normal menses, hormonal levels, and vaginal intercourse after treatment. One patient with rectal cancer died of carcinomatosis 4 months after uterine transposition. One patient presented with uterine necrosis 4 days after uterine transposition, and the uterus was removed; however, one ovary was preserved. Cervical ischemia was the most common post-surgical complication in three (37.5%) patients. Three patients attempted to conceive, and two (66%) were spontaneously successful and delivered healthy babies at 36 and 38 weeks by cesarean section without complications. Conclusions Uterine transposition is a feasible procedure for preserving gonadal and uterine function in patients requiring pelvic radiotherapy for non-gynecological cancer, with the potential for achieving spontaneous pregnancy and successful delivery.
1 January 2013 in Journal of Minimally Invasive Gynecology