Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue

Condition(s) studied

Investigational drug(s) / intervention(s)

Sentinel Lymph Node Detection/Cervical Methylene Blue Injection: Sentinel 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Sentinel Lymph Node (SLN) Detection Rate — 1 day
  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 — 1 day
  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 — 1 day
  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 — 1 day
  Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))

Trial sites (2)

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