Surgery For Endometrial Cancer Research Articles

Laparoscopic surgery for endometrial cancer is oncologically safe and improves hospital stay duration: a retrospective single-center study over a 16-year period.

To investigate changes in surgical procedures and patient outcomes of patients diagnosed with endometrial cancer (EC) at a German university hospital between 1998 and 2014. A monocentric, retrospective review was conducted to identify patients diagnosed and treated with EC during the aforementioned period at the Department of Gynecology and Obstetrics at the University Hospital Kiel, Germany. 303 patients were identified. Patient demographics, risk factors, histological subtypes and stages of EC remained consistent over time. The most common surgical procedure was total abdominal hysterectomy (TAH) (81.9%). In 2011, the institution carried out its first total laparoscopic hysterectomy (TLH) for EC, resulting in a significant increase in laparoscopic surgical procedures (2011-2014: N=70; TAH 44.2%; TLH 51.4%). Although the total number of lymph node stagings remained consistent over time, there was a significant increase in the performance of simultaneous pelvic and para-aortic lymphonodectomy (LNE) compared to pelvic LNE alone (2.6 in 2001-2005 vs. 18.0% in 2011-2014, p≤0.001). The duration of hospital stays significantly decreased over time, with a mean of 20.9days in the first and 8.5days in the last period. When comparing surgical procedures, TLHs resulted in significantly shorter postoperative stays with an average of 6.58 vs. 13.92days for TAH. The surgical procedure performed did not affect 5-year overall survival rates in this study (84.9% for TAH and 85.3% for TLH, p=0.85). Our retrospective single-center study demonstrates that laparoscopic surgery for endometrial cancer is oncologically safe and shortens hospital stays.

Nodal staging in high and high-intermediate risk endometrial cancer surgery: Which role in the molecular classification era?

ObjectivesNodal staging contributes to risk group definition and the indication to adjuvant treatment in endometrial cancer (EC) patients. However, the role of nodal assessment evolved and requires redefinition.Primary outcome of the study was to assess the impact of surgical nodal staging in defining high-risk (HR) EC. Secondary outcome was to evaluate the contribution of nodal assessment to the decision for adjuvant treatment in both high-risk and high-intermediate risk (HIR) patients submitted to surgery. MethodsClinical stage I-II EC patients with postoperative diagnosis of HR and HIR disease were included. The contribution of nodal staging in prognostic groups allocation was assessed by reviewing HR patients to identify those without any other feature of such class (non-endometrioid histology, p53abn immunohistochemistry, post-operative T3-T4 disease) and HIR cases to assess how nodal staging affected adjuvant treatment indication. Descriptive statistics were conducted to describe the two populations. ResultsFifty-seven patients were included, 46 with HR and 11 with HIR disease. Chemotherapy and external-beam radiotherapy (EBRT) were proposed in 40 HR patients. Considering histology, immunohistochemical profile and FIGO stage, high risk classification was exclusively relied on nodal involvement in 2/46 cases (4.3 %). Omitting retroperitoneal staging, one of them would have been classified in the intermediate risk group and the other as HIR: without nodal staging, chemotherapy and EBRT would have been omitted in 1/40 (2.5 %) case.Among HIR patients, chemotherapy was proposed in 7/11 cases and EBRT in all cases. Adjuvant chemotherapy was indicated in 5/6 (83.3 %) and omitted in 1/6 (16.7 %) pN0 patient (stage Ib G2, substantial LVSI). In HIRpN0 patients, omitting nodal staging could have changed adjuvant treatment indication in 1/6 (16.7 %) case. In HIRpNx patients, adjuvant chemotherapy was omitted in one patient (stage II, grade 2 and LVSI negative): nodal staging unavailability might have changed indication to chemotherapy in 1/5 (20 %) case, without changing indication to EBRT.Unavailable nodal staging could globally be related to omission of chemotherapy in 2/57 (3.5 %) patients and of EBRT in 1/57 (1.8 %) patient. ConclusionsIn this series, nodal staging had limited impact on definition of HR class and on the choice of adjuvant treatment in HR and HIR EC patients.

Outcome of robot-assisted surgery for stage IA endometrial cancer compared to open and laparoscopic surgeries: a retrospective study at a single institution.

Few studies have compared the efficacy of robot-assisted, laparoscopic, and open surgeries for endometrial cancer. When considering the position of robotic surgery in Japan, it was necessary to determine whether it was effective or not. We aimed to compare the efficacy and safety of these three types of surgeries for early-stage endometrial cancer. In total, 175 patients with endometrial cancer of preoperative stage IA, who had undergone laparotomic (n = 80), laparoscopic (n = 40), or robot-assisted (n = 55) modified radical hysterectomy at our hospital from 2010 to 2022, were included; surgical outcomes, perioperative complications, and prognoses were compared. Total operative and console times for robot-assisted surgery between patients who did or did not undergo pelvic lymphadenectomy were assessed. The robot-assisted group had the shortest total operative time. The estimated blood loss was lower in the laparoscopic and robot-assisted groups than in the laparotomy group. In advanced postoperative stage IA cases, there were no differences in progression-free and overall survival among the three groups. In the robot-assisted group, the operative time decreased as the number of operations increased; the learning curve was reached after 10 cases each of patients with and without pelvic lymphadenectomy. The frequency of perioperative complications of Clavien-Dindo classification Grade 1 or higher was the lowest in the robot-assisted group (p = 0.02). There were no complications of Clavien-Dindo classification Grade 2 or higher in the robot-assisted group. Robot-assisted surgery for stage IA endometrial cancer, a minimally invasive procedure, has fewer operative times and complications than those of laparoscopic and open surgeries in a single institution in Japan.

Health-Related Quality of Life after Hysterectomy for Endometrial Cancer: The Impact of Enhanced Recovery after Surgery Shifting Paradigm

Objectives: Enhanced recovery after surgery (ERAS) protocols provide well-known benefits in the immediate recovery with a shorter length of stay (LOS) and also in gynecological surgery. However, the impact of ERAS has not been clearly showed yet regarding long-term consequences and health-related quality of life (HRQL). The aim of this study was to investigate the impact of ERAS on HRQL after hysterectomy for endometrial cancer. Design: An observational retrospective study with propensity score matching (PSM) was performed. Participants: We administered the SF-36 validated questionnaire to women underwent hysterectomy and lymph nodal staging before and after introducing ERAS protocol, getting, respectively, a standard practice (SP) and ERAS group. Settings: The study was conducted at the academic hospital. Methods: We collected demographic, clinical, surgical and postoperative data and performed a PSM of the baseline confounders. We administered the questionnaire 4 weeks after the surgery. The SF-36 measures HRQL using eight scales: physical functioning (PF), role physical (RLP), bodily pain (BP), general health (GH), vitality (Vt), social functioning (SF), role emotional (RLE) and mental health (MH). Results: After PSM, we enrolled a total of 154 patients, 77 in each group (SP and ERA). The two groups were similar in terms of age, BMI, anesthetic risk, Charlson comorbidity index (CCI), and surgical technique (minimally invasive vs. open access). Median LOS was shorter for ERAS group (5 vs. 3 days; p = 0.02), while no significant differences were registered in the rates of postoperative complications (16.9% vs. 17.4%; p = 0.66). Response rates to SF-36 questionnaire were 89% and 92%, respectively, in SP and ERAS group. At multivariate analyzes, the mean scores of SF-36 questionnaire, registered at 28 days weeks after surgery (range 26–32 days), were significantly higher in ERAS group for PF (73.3 vs. 91.6; p p = 0.02), and SF (37.5 vs. 58.3; p = 0.01) domains, when compared to SP patients. Limitations: Further follow-up was not possible due to the anonymized data derived from clinical audit. Conclusions: ERAS significantly increases the HRQL of women who underwent surgery for endometrial cancer. HRQL assessment should be routinely implemented in the ERAS protocol.

A Comparative Cohort Study of Laparoscopy Versus Laparotomy for the Treatment of Iranian Endometrial Cancer Patients

Background: In recent decades, laparoscopy and robotic surgery are mostly used for the treatment of endometrial cancer. Laparoscopic surgery's popularity has grown due to rapid postoperative recovery and reduced post-surgical morbidity and complications compared with open surgery. Objectives: This study aimed to compare laparoscopic surgery and laparotomy in terms of their advantages and disadvantages for treating early-stage endometrial cancer in a population of Iranian patients in a referral center of gyneco-oncology. Methods: In this cohort study at Imam Hossein Medical Center in Tehran, Iran, from 2019 to 2022, early-stage endometrial cancer patients were included. Advanced disease, patients with medical comorbidity not suitable for laparoscopy, previous surgery for endometrial cancer, and prior chemotherapy or radiotherapy for treatment of the endometrial cancer were excluded from the study. The study compared two groups regarding operative findings, including FIGO stage, grade, postoperative complications, and hospitalization days. Results: The study included 17 patients in the laparoscopic group with a mean age of 56(+ 12.5) years old and 44 patients in the laparotomy group with a mean age of 57(+ 10.2) years old. Two groups were well-matched in terms of body mass index and menopausal status. The median intraoperative blood loss was significantly in terms of statistical less in the laparoscopic group (200 ml versus 500 ml, P = 0.001). Four (23.5%) patients in the laparoscopic group needed intraoperative blood transfusion versus 22 (50.0%) in the laparotomy group, P = 0.061. Hospital stay days were shorter in the laparoscopic group, with a median of three versus six days (P < 0.001). Conclusions: In conclusion, the minimally invasive operation caused less blood loss, hospital stay, and blood transfusion in comparison to laparotomy in Iranian endometrial cancer patients, confirming the preferred method of laparoscopy in these patients.

Short-Term Outcomes After Hysterectomy for Endometrial Cancer/EIN With Concomitant Pelvic Floor Disorder Surgery.

Endometrial cancer and precancer are common gynecologic problems for many women. A majority of these patients require surgery as the mainstay of treatment. Many of these patients often have concurrent pelvic floor disorders. Despite the prevalence and shared risk, fewer than 3% of women undergo concomitant surgery for PFDs at the time of surgery for endometrial cancer or endometrial intraepithelial neoplasia/hyperplasia. This study aimed to evaluate postoperative morbidity of concomitant pelvic organ prolapse (POP) and/or urinary incontinence (UI) procedures at the time of hysterectomy for endometrial cancer (EC) or endometrial intraepithelial neoplasia/endometrial hyperplasia (EIN/EH). This retrospective analysis of women undergoing hysterectomy for EC or EIN/EH between 2017 and 2022 used the American College of Surgeons National Surgical Quality Improvement Program database. The primary outcome was any major complication within 30 days of surgery. Comparisons were made between 2 cohorts: hysterectomy with concomitant pelvic organ prolapse/urinary incontinence procedures (POPUI) versus hysterectomy without concomitant POP or UI procedures (HYSTAlone). A subgroup analysis was performed in patients with EC. A propensity score matching cohort was also created. A total of 23,144 patients underwent hysterectomy for EC or EIN/EH: 1.9% (n = 432) had POP and/or UI procedures. Patients with POPUI were older, were predominantly White, had higher parity, and had lower body mass index with lower American Society of Anesthesiologists class. Patients with POPUI were less likely to have EC (65.7% vs 78.3%, P < 0.0001) and more likely to have their hysterectomy performed by a general obstetrician- gynecologists or urogynecologists. Major complications were low and not significantly different between POPUI and HYSTAlone (3.7% vs 3.6%, P = 0.094). A subgroup analysis of EC alone found that the HYSTAlone subset did not have more advanced cancers, yet the surgeon was more likely a gynecologic oncologist (87.1% vs 68.0%, P < 0.0001). There were no statistically significant differences between the 2 cohorts for the primary and secondary outcomes using propensity score matching analysis. Concomitant prolapse and/or incontinence procedures were uncommon and did not increase the rate of 30-day major complications for women undergoing hysterectomy for EC/EH.

Impact of sentinel lymph node mapping on survival in patients with high-risk endometrial cancer in the early stage: A matched cohort study.

The aim of this study was to compare patient survival using sentinel lymph node (SLN) procedure and pelvic lymphadenectomy for stating early-stage high risk endometrial cancer. Patients who underwent surgery for early-stage high risk endometrial cancer between 2010 and 2017 were extracted from the incidence registry of the SEER program. We identified patients who underwent SLN mapping. Patients who initially underwent pelvic lymphadenectomy were selected as the comparison group. One-to-one matching was performed according to age, ethnicity, histology, extension and grade. The primary outcome was disease-specific survival. The secondary outcome was overall survival. A total of 326 patients who underwent SLN mapping and 326 who underwent pelvic lymphadenectomy initially were included in the study. The three-year analysis did not find a significant difference between the SLN and lymphadenectomy groups on disease-specific survival probability (88.2% vs 82.7, P = 0.07) and on overall survival probability (82.7% vs 78.2%, P = 0.57). Patients who underwent SLN mapping had a lower mean number of lymph nodes removed (mean 3 vs 16, P < 0.001) and there was a higher rate of patients with positive pelvic lymph nodes (18% vs 14%, P = 0.04). Following adjustment for confounding factors, disease-specific survival did not vary according to the lymph node intervention performed (P = 0.056), but the SLN group had better overall survival than those in the lymphadenectomy group (P = 0.047). The SLN technique was not associated with poorer disease-specific survival than pelvic lymphadenectomy even after adjustment. These results suggest that SLN is an acceptable and safe procedure in surgical staging for early-stage high-risk endometrial cancer.

Robotic surgery in endometrial cancer: first Polish experience.

In Poland, robotic surgery is nowadays perceived as a new method of surgical treatment in endometrial cancer patients. We aim to present the first Polish group of endometrial cancer patients treated using robotic surgery. The analysis was based on 79 patients with mean age of 59.72 ± 11.709 (range 27-83) years and endometrial cancer scheduled for surgical treatment. Mean BMI was 31.38 ± 8.78 (range 19.03-65.97)kg/m2. The data were collected based on a questionnaire consisting of 19 questions concerning the patient's perception of robotic surgery before the procedure. Patients with a family history of neoplastic diseases indicate precision of movements as the most important reason for choosing robotic surgery (p = 0.0035). Patients after surgery procedures in the past named shorter hospitalization as a major benefit (p = 0.0037). Patients who chose robotic surgery for financial reasons stressed the cosmetic effect as a priority (p = 0.0319). Shorter length of hospital stay, less blood loss, enlarged view, and good visualization were statistically significant reasons for choosing robotic surgery (p < 0.05). Women who consider work, good material status, and well-being as the most important aspects of their lives cited the cosmetic effect as a benefit of robotic surgery (p = 0.0029 vs. p = 0.0074 vs. p = 0.01745, respectively). In the follow-up after operations, no patients regretted choosing robotic surgery. Good visualization, precise movements, less blood loss, and cosmetic effects are the most frequent reasons for choosing robotic surgery. Even patients after other types of surgery in the past decided on robot-assisted radical hysterectomy because of the clear benefits of this approach.

Robotic-assisted surgery for endometrial cancer: a comparison of surgical and oncologic outcomes in patients with low and high BMI at an Indian tertiary care center

The robotic-assisted surgery for endometrial cancer (EC) is becoming increasingly important, owing to the superior surgical outcomes. However, efficacy data from India is limited, particularly for older women who are obese. We undertook this study to compare the surgical outcomes of robotic-assisted surgery among Indian EC patients with a BMI of < 30 and ≥ 30 kg/m2. A retrospective chart review was conducted for the period of May 2016 to October 2020. Data on patient demographics, medical history, clinical characteristics, and perioperative outcomes were collected by a single senior surgeon, followed by statistical analysis. A total of 99 patients; 39 in the BMI group < 30 and 60 in the BMI group ≥ 30 kg/m2 were included in the study. The mean age of the BMI groups < 30 and ≥ 30 kg/m2 was 60.92 ± 10.43 and 58.90 ± 8.52 years respectively (P = 0.2944). The mean total operating time was slightly higher in the BMI group < 30 kg/m2 (P = 0.8552) but the difference was not statistically significant. Similarly, the mean blood loss (P = 0.2041), length of hospital stays (P = 0.6564), early (P = 0.7758) and delayed complications (P = 0.1878) were less in the BMI group < 30 kg/m2 but the difference was not statistically significant either. At a median follow-up of 22.3 months, the number of recurrences (5.13% vs 3.33%) and deaths (2.56% vs 1.67%) were more in BMI < 30 kg/m2 group. Our study suggests that obese older women predisposed to multiple medical co-morbidities and surgical complications would especially benefit from robotic-assisted technology regardless of their BMI.

Recent management of endometrial cancer: a narrative review of the literature.

Endometrial cancer is a common female gynecological neoplasia and its incidence rate has increased in the past years. Due to its predominant symptoms, most women will present uterine bleeding. It is usually diagnosed at an early stage and surgery has an important role in the treatment plan. The prognosis and quality of life of these patients can be quite favorable, if proper treatment is offered by surgeons. Traditionally, more invasive approaches and procedures were offered to these patients, but recent data suggest that more conservative and minimal invasive choices can be adopted in the treatment algorithm. Minimal invasive surgery, such as laparoscopy and robotic surgery, should be considered as an acceptable alternative, compared to laparotomy with less comorbidities and similar oncological and survival outcomes. Furthermore, sentinel lymph node biopsy has emerged in the surgical staging of endometrial cancer, in order to replace comprehensive lymphadenectomy. It is associated with less intra- and postoperative complications, while preliminary data show no difference in survival rates. However, sentinel lymph node biopsy should be offered within a strict algorithm, to avoid residual metastatic disease. The aim of this review is to analyze all the available data for the application of minimal invasive surgery in early endometrial cancer and especially the role of sentinel lymph node biopsy.

The Impact of Intrauterine Manipulators on Outcome and Recurrence Patterns of Endometrial Cancer Patients Undergoing Minimally Invasive Surgery.

Objective: To evaluate the use of manipulators on the outcome of women who had minimally invasive surgery for endometrial cancer. Methods: Retrospective analysis of patients operated with or without an intrauterine manipulator. Results: Six hundred ninety-nine patients were included. The median follow-up was 44 months (range, 29-67). Nineteen (8.8%) patients had positive cytology in the manipulator group versus 21 (4.4%) in the comparison group (p = 0.02). Total recurrence rate was similar between the groups (12.3% vs. 11.9%; p = 0.8). Vaginal vault recurrence was the most common site of recurrence with higher incidence in the manipulator group (4.5% vs. 1.3%; p = 0.007). Subgroup analysis of low-risk patients who did not receive adjuvant treatment showed higher recurrence rate (8.3% vs. 3%; p = 0.023) and worse disease-free survival (p = 0.01) for the manipulator group. After controlling for other variables, the use of a manipulator did not affect the risk of recurrence for the whole cohort (hazard ratio [HR], 1.28; confidence interval [95% CI], 0.7-2.1, p = 0.3) and for the low-risk subgroup of patients who did not receive adjuvant treatment (HR, 2.47; 95% CI, 0.8-7, p = 0.08). Conclusion: The use of a manipulator increases the risk of positive cytology as well as vaginal vault recurrences, but it does not reduce the overall survival of patients.

Retroperitoneal sentinel lymph node biopsy by transvaginal natural orifice transluminal endoscopic surgery in early-stage endometrial cancer.

Retroperitoneal sentinel lymph node biopsy by transvaginal natural orifice transluminal endoscopic surgery in early-stage endometrial cancer.

Cancer-field surgery for endometrial cancer by robotic peritoneal mesometrial resection and targeted compartmental lymphadenectomy (PMMR+TCL)

Cancer-field surgery for endometrial cancer by robotic peritoneal mesometrial resection and targeted compartmental lymphadenectomy (PMMR+TCL)

Enhanced recovery after single-site robotic staging surgery of endometrial cancer

Enhanced recovery after single-site robotic staging surgery of endometrial cancer

Is robotic surgery beneficial for the treatment of endometrial cancer? A comparison with conventional laparoscopic surgery.

Objective: The objective of this study was to compare the oncologic outcomes between those who underwent robotic surgery or conventional laparoscopic surgery for endometrial cancer. Method: We performed a retrospective review of patients from a single institution who underwent either laparoscopic or robotic surgery for the treatment of endometrial cancer between January 2010 and December 2020. Tumor characteristics, recurrence rate, disease-free survival, and overall survival were compared according to surgical approach. Results: Among the 268 patients included in this study, 95 underwent robotic surgery (35.4%) and 173 underwent laparoscopic surgery (64.6%). The median follow-up durations were 51 and 59 months for the robotic surgery and laparoscopic surgery groups, respectively (p = 0.085). The recurrence rate did not differ significantly between the two groups. (p = 0.371). Disease-free survival (p = 0.721) and overall survival (p = 0.453) were similar between the two groups. In both univariate and multivariate analyses, the type of surgery was not related to disease-free survival. The median total cost per admission was significantly higher for RS than for LS (12,123 vs. 6,884 USD, p < 0.0001). Conclusion: With consistently greater costs and similar survival outcomes, robotic systems have few advantages compared with laparoscopy.

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology consensus statement.

The Korean Society of Gynecologic Oncology (KSGO) had been making an effort to standardize and enhance the quality of domestic uterine corpus cancer treatment by developing updated clinical practice guidelines in 2021. The KSGO revised the guidelines based on a literature search using 4 key elements: Population, Intervention, Comparison, and Outcome framework. These elements include the evaluation of the efficacy and safety of immune checkpoint inhibitor treatment in recurrent/advanced endometrial cancer patients who have failed platinum-based chemotherapy, as well as the effect of combined treatment with trastuzumab in patients with HER2/neu-positive endometrial cancer. Additionally, the guideline assessed the efficacy and safety of omitting lymph node dissection in low-risk endometrial cancer patients, investigated the effect of sentinel lymph node mapping in early-stage endometrial cancer surgery, addressed the outcome of chemoradiation therapy as a postoperative treatment in patients with advanced (stage III-IVA) endometrial cancer, and explored the impact of initial treatment with immune checkpoint inhibitors on survival in patients with advanced or recurrent endometrial cancer patients.

Retracted: Clinical Application of Digital 3D Reconstruction and 3D Printing Technology in Endometrial Cancer (EC) Surgery.

[This retracts the article DOI: 10.1155/2022/9180216.].

Comparing the survival rates of patients with stage IIIC endometrial cancer undergoing sandwich therapy to those undergoing sequential chemotherapy and radiotherapy: a meta-analysis.

The use of additional treatment after surgery for stage IIIC endometrial cancer (EC) according to the Federation of Gynecology and Obstetrics (FIGO) is still a topic of discussion. This meta-analysis examined the effects of sandwich treatment and sequential treatment on the survival of individuals diagnosed with stage IIIC EC. We examined the literature from various databases regarding the overall survival (OS) and adverse effects of the two additional therapies following surgery in individuals diagnosed with stage IIIC EC. Revman 5.4.1 was utilized to combine hazard ratios (HR) and their corresponding 95% confidence intervals (95% CI) for OS and toxicities. The findings comprised of five retrospective investigations involving a combined total of 800 individuals. The patients who underwent sandwich treatment did not demonstrate a notable improvement in survival rates over a period of 3years. Upon eliminating the impact of extensive samples, it was discovered that sandwich therapy exhibited a superior 5-year overall survival compared to patients receiving sequential therapy. The effectiveness of sandwich therapy was superior to sequential therapy in terms of a 3-year OS for non-endometrioid histology, although the outcome did not reach statistical significance. The toxicities of both treatments were similar. In terms of long-term survival, sandwich therapy was found to be more advantageous than sequential therapy for patients with stage IIIC EC, with no significant disparity observed in the 3-year OS and toxicities between the two treatments. Sandwich therapy exhibited a tendency towards improved effectiveness in patients with histology other than endometrioid.

Robot-assisted Surgery with Para-aortic Lymphadenectomy for Endometrial Cancer: A Preliminary Report.

There are few reported cases of robot-assisted surgery for endometrial cancer with para-aortic lymphadenectomy (PAL) in Japan. Therefore, this study aimed to examine the clinical outcomes of robot-assisted surgery with PAL for endometrial cancer. This retrospective cohort study was analyzed 13 endometrial cancer patients who underwent robotic surgery with PAL between January 2011 and October 2018 at our hospital. We examined their perioperative complications and oncological outcomes. The median follow-up period, median overall survival, and disease-free interval were 80 months, 79 months (61-120), and 79 months (5-120), respectively. There were two (15.3%) cases of perioperative complications of Clavien-Dindo Class II or higher and three (23.0%) cases of recurrence. Our results showed that the surgical and oncological outcomes of robot-assisted surgery for endometrial cancer with PAL were comparable with those of other developed countries.

A multicenter noninferior randomized controlled study of sentinel lymph node biopsy alone versus sentinel lymph node biopsy plus lymphadenectomy for patients with stage I endometrial cancer, INSEC trial concept

BackgroundUp to the present time, there has remained a lack of strong evidence as to whether sentinel lymph node biopsy can replace lymphadenectomy for early endometrial cancer. The traditional surgery for endometrial cancer includes pelvic lymphadenectomy and paraaortic lymph node resection, but complications often seriously affect patients’ quality of life. Two randomized controlled trials with large samples have proved that lymphadenectomy does not improve the overall recurrence rate and survival rate of patients. On the contrary, it increases the incidence of complications and even mortality. The current trial is designed to clarify whether sentinel lymph node biopsy can replace lymphadenectomy for early endometrial cancer patients with negative lymph nodes.MethodsThis study is a randomized, open-label, multicenter and non-inferiority controlled clinical trial in China. Potential participants will be patients with pathologically confirmed endometrial cancer at the Zhejiang Cancer Hospital, Jiaxing Maternity and Child Health Care Hospital, and the First Hospital of Jiaxing in China. The total sample size for this study is 722.Patients will be randomly assigned in a 1:1 ratio to two groups. Patients in one group will undergo sentinel lymph node biopsy + total hysterectomy + bilateral salpingo-oophorectomy ± paraaortic lymph node resection. Patients in the other group will undergo sentinel lymph node biopsy + total hysterectomy + bilateral salpingo-oophorectomy + pelvic lymphadenectomy ± paraaortic lymph node resection. The 3-year disease-free survival rate, overall survival rate, quality of life (use EORTC QLQ-C30 + QLQ-CX24), and perioperative related indexes of the two groups will be compared.ResultsWe expect to find that for patients with early endometrial cancer, the 3-year disease-free survival rate following sentinel lymph node biopsy with indocyanine green combined with near-infrared fluorescence imaging is similar to that following lymphadenectomy. The operation time, as well as incidence of pelvic lymphocyst, lymphedema of lower limb, and edema of vulva in patients who only undergo sentinel lymph node biopsy are expected to be significantly lower than in patients who undergo lymphadenectomy. The quality of life of patients who undergo sentinel lymph node biopsy alone will be significantly better than that of patients who undergo lymph node dissection.ConclusionThis will prove that the prognosis of sentinel lymph node biopsy alone with indocyanine green combined with near-infrared fluorescence imaging is not inferior to that of sentinel lymph node biopsy plus lymphadenectomy for early stage endometrial cancer with negative nodal assessment intraoperatively. In addition, sentinel lymph node biopsy alone with indocyanine green combined with near-infrared fluorescence imaging results in fewer surgical complications and gives patients better quality of life.Trial registrationchictr.org.cn, ChiCTR1900023161. Registered 14 May 2019, http://www.chictr.org.cn/edit.aspx?pid=38659&htm=4.