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

Fudan University

Status: Withdrawn

Conditions: Endometrial Endometrioid Adenocarcinoma

Treatments: Procedure: SLN arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03677024

53201012

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

SLN arm

Experimental group

Description:

Experimental: 1. Intra-operative sentinel lymph node (SLN) mapping with indocyanin green injected into the stroma of the cervix. 2. 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.

Treatment:

Procedure: SLN arm

Lymphadenectomy arm

No Intervention group

Description:

Surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.