NCT04972682

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

Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Moscow City Oncology Hospital No. 62 · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

Conditions

• Endometrial Cancer
• Endometrial Neoplasms
• Endometrial Adenocarcinoma
• Endometrial Cancer Stage I
• Endometrial Cancer Stage II
• Endometrial Endometrioid Adenocarcinoma
• Sentinel Lymph Node
• Hysterectomy
• Laparoscopic Hysterectomy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-08-15
• Completion: 2024-04-15
• First posted: 2021-07-22
• Last updated: 2024-05-07

Locations

1 site across 1 country: Russia