Stage III Endometrial Carcinoma Clinical Trial
Official title:
Sentinel Lymph Node Mapping for Endometrial Cancer
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
PRIMARY OBJECTIVES:
I. To determine the detection rate, sensitivity, and negative predictive value of sentinel
lymph node (SLN) biopsy in endometrial cancer patients.
SECONDARY OBJECTIVES:
I. To compare different surgical modalities (open procedures, minimally invasive procedures,
and single-site technology) and different injectants (isosulfan blue and indocyanine green)
for SLN biopsy.
II. To determine total operating room time (from the time the patient enters the room to the
time the patient leaves the room) as well as console time (robotic)/operating time for
minimally invasive procedures.
OUTLINE:
Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected
directly into the cervix. Following SLN identification and biopsy, patients undergo
hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy.
Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
After completion of study treatment, patients are followed up at 2-4 weeks.
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