Endometrial Endometrioid Adenocarcinoma
Conditions
Keywords
Sentinel lymph node policy
Brief summary
To evaluate the efficacy of sentinel lymph node policy in patients with intermediate-risk endometrial carcinomas
Detailed description
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.
Interventions
PROCEDURESLN arm
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.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. No contraindication to surgery. 3. Signed and dated informed consent. 4. Intermediate-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations). 5. Without any suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.
Exclusion criteria
1. Low-risk endometrioid cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations). 2. Grade 3 endometrioid cancer (in preoperative pathological diagnosis or in intraoperative frozen section examinations). 3. Deep muscular infiltration (in intraoperative frozen section examinations). 4. Cervical invasion and/or ovarian/tubal invasion (in intraoperative frozen section examinations). 5. With suspicious pelvic, paraaortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/PET-CT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance Analysis | Within 14 days after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 1 years after the surgery | Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc. |
| Recurrence rate | 5 years after the surgery | The recurrence rate of different groups will be followed up. |
| Adjuvant therapy rate | 5 years after the surgery | The adjuvant therapy rate of different groups will be followed up. |
| 5-year survival rate | 5 years after the surgery | The 5-year survival rate of different groups will be followed up. |
Countries
China
Outcome results
None listed