Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
Dokuz Eylul University
100 participants
May 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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.
Exclusion Criteria14
- Medical Conditions
- 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.
- Women with multiple and confluent lymph nodes identified as positive on FDG-PET/CT (such cases are not considered stage I).
- Cancer-Related Conditions
- Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.
- Individuals with a history of pelvic dissection and/or radiation therapy.
- Individuals with advanced cervical or uterine cancer.
- Individuals with T3/T4 lesions.
- Individuals with cervical tumors larger than 2 cm.
- Organ Dysfunction
- • Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07040657