Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas

Study Overview
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Brief Summary
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To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas

Detailed Description
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Surgical assessment for staging of endometrial carcinoma during primary surgery remains one of the most varied practices worldwide, as it may include no nodal assessment, sentinel node mapping, and complete pelvic and aortic lymphadenectomy up to the renal vessels. Since lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, gynecologists agree that pelvic and aortic lymphadenectomy should be routinely performed in high-risk patients (grade 3, deep myometrial invasion, type 2 cancer). However, whether lymphadenectomy is required in patients with endometrioid endometrial cancers of grade 1 or 2 and with less than 50% myometrial invasion is controversial. Then, the investigators conducted this prospective cohort study to investigate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas (grade 1 or 2, < 50% myometrial invasion, and a tumor diameter ≥ 2 cm) as well as their outcomes. Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.

Official Title
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Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas

Conditions
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Endometrial Endometrioid Adenocarcinoma

Intervention / Treatment
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* Procedure: SLN arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. No contraindication to surgery. Signed and dated informed consent. Intermediate-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations). Without any suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT. Exclusion Criteria: Low-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter < 2cm (in intraoperative frozen section examinations). Grade 3 endometrioid cancer (in preoperative pathological diagnosis or in intraoperative frozen section examinations). Deep muscular infiltration (in intraoperative frozen section examinations). Cervical invasion and/or ovarian/tubal invasion (in intraoperative frozen section examinations). With suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLN arm<br>Experimental: Intra-operative sentinel lymph node (SLN) mapping with indocyanin green injected into the stroma of the cervix. Full bilateral laparoscopic lymphadenectomy and hysterectomy: If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceeds to a total hysterectomy. If only unilateral SLN are detected, surgeons will proceed to pelvic lymphadenectomy on the opposite side. If non SLN are detected, surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy. | Procedure: SLN arm<br>* Intra-operative SN mapping with indocyanin green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and another 1ml will be injected superficially (2mm-depth). The time between the injection and the search for SLN must be as soon as possible.<br>|
| No Intervention: Lymphadenectomy arm<br>Surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Analysis | Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease. | Within 14 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc. | 1 years after the surgery | 
| Recurrence rate | The recurrence rate of different groups will be followed up. | 5 years after the surgery | 
| Adjuvant therapy rate | The adjuvant therapy rate of different groups will be followed up. | 5 years after the surgery | 
| 5-year survival rate | The 5-year survival rate of different groups will be followed up. | 5 years after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node policy