Investigator
Obstetrics And Gynecology Hospital Of Fudan University
Comparison of the effect of oral megestrol acetate with or without levonorgestrel-intrauterine system on fertility-preserving treatment in patients with early-stage endometrial cancer: a prospective, open-label, randomized controlled phase II trial (ClinicalTrials.gov NCT03241914)
To evaluate the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) plus oral megestrol acetate (MA) as fertility-preserving treatment in patients with early-stage endometrial cancer (EEC). In this single-center, phase II study with open-label, randomized and controlled design, young patients (18-45 years) diagnosed with primary EEC were screened, who strongly required fertility-preserving treatment. Patients were randomly assigned (1:1) into MA group (160 mg oral daily) or MA (160 mg oral daily) plus LNG-IUS group. Pathologic evaluation on endometrium retrieved by hysteroscopy was performed every 3 months. The primary endpoint was complete response (CR) rate within 16 weeks of treatment. The secondary endpoints were CR rate within 32 weeks of treatment, adverse events, recurrent and pregnancy rate. Between July 2017 and June 2020, 63 patients were enrolled and randomly assigned. Totally 56 patients (26 in MA group; 28 in MA + LNG-IUS group) were included into primary-endpoint analyses. The median follow-up was 31.6 months (range, 3.1-94.0). No significant difference in 16-week CR rate were found between MA and MA + LNG-IUS groups (19.2% vs. 25.0%, p=0.610; odds ratio=1.40; 95% confidence interval=0.38-5.12), while the 32-week CR rates were also similar (57.1% and 61.5%, p=0.743), accordingly. More women in MA + LNG-IUS group experienced vaginal hemorrhage (46.4% vs. 16.1%; p=0.012) compared with MA group. No intergroup difference was found regarding recurrence or pregnancy rate. Compared with MA alone, the addition of LNG-IUS may not improve the early CR rate for EEC, and may produce more adverse events instead. ClinicalTrials.gov Identifier: NCT03241914.
Constructing a prediction model for lymph node metastasis in patients with incidental finding of endometrial cancer based on Fully-Connected Network
Rare studies focused on patients with incidental diagnosis of endometrial cancer (EC) after hysterectomy. We intended to construct a prediction model of lymph node metastasis (LNM) based on Fully-Connected Network (FC Network) for these patients. A total of 3,920 cases of EC that met the criteria from Obstetrics & Gynecology Hospital of Fudan University between January 2016 and February 2023 and 1995 cases from Fudan University Shanghai Cancer Center between January 2013 and October 2020 were retrospectively included for the construction of a predicting model which was based on FC Network. At the same time, 572 cases were prospectively collected for external validation. The sensitivity of the model was 0.946. Lympho-vascular space invasion, myometrial invasion, tumor grade, microcystic elongated and fragmented invasion, progesterone receptor, and cancer antigen 125 were used to construct a simplified nomogram. The area under the curve of the nomogram was 0.890 and 0.885 in validation and prospective cohorts, respectively. The model we proposed has good sensitivity and can be used to predict the risk of LNM in patients with incidentally found EC. The simplified nomogram can be used as a substitute in certain situations. Based on another study, the threshold of 5% and 25% can be used for risk stratification.
Laparoscopic Resection of a Parasitic Leiomyoma of Mesentery Following Myomectomy
To illustrate the laparoscopic removal of a parasitic leiomyoma in the mesentery, which developed from a morcellation remnant following a laparoscopic myomectomy. University hospital. A stepwise surgical demonstration with narrated video footage. A patient with a large pelvic mass two years after undergoing laparoscopic myomectomy. The 31-year-old patient underwent laparoscopic myomectomy approximately two years prior, with no record of contained morcellation. Based on our inference, it is likely that a retrieval bag was not utilized during the previous fibroid morcellation. The postoperative pathology was confirmed as leiomyoma. She presented with abdominal bloating. An ultrasound at our hospital revealed an 8.2cm x 8.3cm x 7.3cm hypoechoic, irregular mass on the right side of the uterus. Pelvic magnetic resonance images (MRI) showed a mass of 6.9cm x 5.2cm x 9.7cm in the right anterior uterus with clear margins, hypointense on T2-weighted imaging, isointense on T1-weighted imaging, and significant post-contrast enhancement. Cancer antigen 125 and 199 were in normal range. Laparoscopy was performed, following these key steps: First, identifying the location of the mass and the orientation of the intestinal tract. Second, opening the pseudocapsule along the longitudinal axis of the mass. Third, gradually separating the mass from mesentery. Fourth, suturing the wound of mesentery. Finally, performing contained electromechanical morcellation. The final pathology confirmed leiomyoma. The laparoscopic resection of a parasitic leiomyoma in the mesentery is feasible and safe. The critical point of the procedure is to confirm the orientation of intestinal tract and identify the anatomical space between the mass and mesentery [1]. It is possible that the use of a contained retrieval bag could have prevented the need for this surgery.
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.