This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.
Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.
Individuals diagnosed with dementia.
Individuals with allergies to methylene blue or iodine.
Individuals who have received active treatment for another malignancy within the past five years.
Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.
Parallel
Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
Procedure/SurgerySentinel Lymph Node (SLN) detection using cervical methylene blue injection is a surgical technique designed to identify the primary lymph nodes responsible for draining the uterus in patients with endometrial cancer. The procedure involves injecting methylene blue dye into specific locations within the cervical stroma to enable lymphatic uptake. The dye subsequently travels through the lymphatic channels, allowing for intraoperative visual identification of the sentinel nodes. This targeted approach facilitates selective SLN excision for pathological evaluation, providing critical information about lymphatic involvement while minimizing the extent of surgical dissection. The effectiveness of SLN mapping is contingent upon the accuracy of the injection technique and the anatomical distribution of lymphatic drainage.
Sentinel Lymph Node (SLN) Detection Rate
The detection rate will be measured as the number of sentinel lymph nodes identified using methylene blue divided by the total number of lymph nodes excised during surgery. Comparison will be made between the two-point and four-point cervical injection techniques. (Unit of Measure: Proportion (%))
Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases
Sensitivity will be calculated as the proportion of true positive SLNs (confirmed by histopathology) over the total number of lymph nodes with metastases. (Unit of Measure: Percentage (%))
Specificity of SLN Biopsy for Detecting Lymph Node Metastases
Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis. (Unit of Measure: Percentage (%))
Rate of Positive SLNs Detected
Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))
Procedure Duration
Total time in minutes from injection to identification of sentinel lymph nodes (SLNs), recorded and compared between two-point and four-point cervical injection techniques. (Unit of Measure: Minutes)
Complications and Side Effects - Injection-Related Side Effects
Incidence of side effects related to methylene blue injection (e.g., allergic reaction, local pain, or discoloration at the injection site), recorded during and after the procedure. (Unit of Measure: Number of events and proportion (%))
SLN Anatomical Distribution
Number and proportion of detected SLNs located in specific anatomical regions (e.g., pelvic, para-aortic) for each injection technique. (Unit of Measure: Number and Proportion (%))
Surgical Complications
Incidence of postoperative complications related to SLN mapping, including infection, hematoma, and lymphedema. (Unit of Measure: Number of events and proportion (%))
Click on the lead sponsor to view all of their trials.
