[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

NACompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

August 15, 2023

Study Completion Date

April 15, 2024

Conditions
Endometrial CancerEndometrial NeoplasmsEndometrial AdenocarcinomaEndometrial Cancer Stage IEndometrial Cancer Stage IIEndometrial Endometrioid AdenocarcinomaSentinel Lymph NodeHysterectomyLaparoscopic Hysterectomy
Interventions
PROCEDURE

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.

Trial Locations (1)

143515

1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62, Istra

All Listed Sponsors
lead

Moscow City Oncology Hospital No. 62

OTHER_GOV