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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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.
1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62
Istra, Moscow Oblast, Russia
Change in postoperative treatment strategy
The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.
Time frame: Up to 3 weeks after surgery
Adjustments in FIGO staging
The rate of change in disease stage based on SLNB results and postoperative histology (percentage).
Time frame: Up to 3 weeks after surgery
Bilateral SLN detection
The rate of bilateral SLN detection (percentage).
Time frame: At the end of the surgery - 1 day
Details of intraoperative complications of SLN biopsy
The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG).
Time frame: At the end of the surgery - 1 day
The rate of intraoperative complications of SLN biopsy
Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.
Time frame: At the end of the surgery - 1 day
Major postoperative morbidity
Major postoperative morbidity following the procedure (percentage).
Time frame: Up to 30 days after surgery
Postoperative mortality
Postoperative mortality following the procedure (percentage).
Time frame: Up to 30 days after surgery
Incidence of lymphedema
The rate of lower extremities lymphedema (percentage).
Time frame: Up to 24 months after surgery
Pelvic recurrence rate
The percentage of patients experiencing pelvic recurrence after surgical treatment.
Time frame: 24 months after surgery
Time to pelvic recurrence
Time from surgical treatment to detected pelvic recurrence in months.
Time frame: 24 months after surgery
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