Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
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|ClinicalTrials.gov Identifier: NCT03716414|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment|
|Endometrial Adenocarcinoma||Procedure: SLN mapping|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental SLN arm
Experimental SLN arm
If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceed to a total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy including complete pelvic lymphadenectomy and aortic lymph node dissection.
If only unilateral SLN or non SLN are detected, surgeons will proceed to complete pelvic lymphadenectomy and aortic lymph node dissection.
Procedure: SLN mapping
Intra-operative SLN mapping with indocyanine 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 Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth).
The time between the injection and the search for SLN must be as soon as possible.
- 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 ]calculate 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 will be followed up.
- Adjuvant therapy rate [ Time Frame: 5 years after the surgery ]The adjuvant therapy rate will be followed up.
- 5-year survival rate [ Time Frame: 5 years after the surgery ]The 5-year survival rate 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): NCT03716414
|Contact: Xiaojun Chen, Ph.D.||+86 021-33189900 ext email@example.com|
|Contact: Chao Wang, Ph.D.||+86 021-33189900 ext firstname.lastname@example.org|
|Obstetrics and Gynecology Hospital, Fudan University||Recruiting|
|Contact: Chao Wang|
|Study Director:||Chao Wang, Ph.D.||Obstetrics and Gynecology Hospital, Fudan University|
|Principal Investigator:||Xuezhen Luo, Ph.D.||Obstetrics and Gynecology Hospital, Fudan University|
|Study Chair:||Xiaojun Chen, Ph.D.||Obstetrics and Gynecology Hospital, Fudan University|