To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China
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.
Time frame: Within 14 days after the surgery
Postoperative complications
Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.
Time frame: 1 years after the surgery
Recurrence rate
The recurrence rate of different groups will be followed up.
Time frame: 5 years after the surgery
Adjuvant therapy rate
The adjuvant therapy rate of different groups will be followed up.
Time frame: 5 years after the surgery
5-year survival rate
The 5-year survival rate of different groups will be followed up.
Time frame: 5 years after the surgery
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