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

Not Applicable

Withdrawn

• Conditions: Endometrial Endometrioid Adenocarcinoma
• Interventions: Procedure: SLN arm

• Registration Number: NCT03677024
• Lead Sponsor: Fudan University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Start: 2020-02-06
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SLN arm	SLN arm	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative complications	1 years after the surgery	Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.
Adjuvant therapy rate	5 years after the surgery	The adjuvant therapy rate of different groups will be followed up.
Recurrence rate	5 years after the surgery	The recurrence 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.

Trial Locations

Locations (1)

Obstetrics and Gynecology Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China