RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: 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.

Treatments Being Tested

PROCEDURE

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.

Locations (2)

Ankara University

Ankara, Turkey (Türkiye)

Dokuz Eylul University

Izmir, Turkey (Türkiye)