Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas
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|ClinicalTrials.gov Identifier: NCT03677024|
Recruitment Status : Withdrawn (This study was not approved by the Ethics Committee)
First Posted : September 19, 2018
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Endometrioid Adenocarcinoma||Procedure: SLN arm||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy for Sentinel Lymph Node Policy in Intermediate-risk Endometrial Carcinomas|
|Estimated Study Start Date :||February 6, 2020|
|Estimated Primary Completion Date :||October 7, 2021|
|Estimated Study Completion Date :||October 7, 2021|
Experimental: SLN arm
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
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.
No Intervention: Lymphadenectomy arm
Surgeons will proceed to a total hysterectomy, a bilateral salpingo-oophorectomy, a complete and bilateral pelvic lymphadenectomy.
- Performance Analysis [ Time Frame: 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.
- Postoperative complications [ Time Frame: 1 years after the surgery ]Comparison of the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.
- Recurrence rate [ Time Frame: 5 years after the surgery ]The recurrence rate of different groups will be followed up.
- Adjuvant therapy rate [ Time Frame: 5 years after the surgery ]The adjuvant therapy rate of different groups will be followed up.
- 5-year survival rate [ Time Frame: 5 years after the surgery ]The 5-year survival rate of different groups will be followed up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677024
|Obstetrics and Gynecology Hospital, Fudan University|
|Shanghai, Shanghai, China, 200011|
|Principal Investigator:||Xiaojun Chen, PhD||Obstetrics and Gynecology Hospital, Fudan University|