RecruitingNot ApplicableNCT07040657

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

Sponsor

Dokuz Eylul University

Enrollment

100 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Sentinel Lymph Node Metastasis Endometrial Neoplasms Endometrial Cancer Stage I

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different injection techniques for mapping sentinel lymph nodes in patients with early-stage uterine cancer (endometrial cancer). Sentinel lymph node mapping helps surgeons find the first lymph nodes that cancer might spread to. The study uses a dye called methylene blue and compares injecting it in two spots versus four spots around the cervix. **You may be eligible if...** - You have been diagnosed with stage I endometrial cancer, confirmed by imaging (CT and PET-CT) and tissue biopsy **You may NOT be eligible if...** - You have been diagnosed with dementia - You have an allergy to methylene blue or iodine - You have been actively treated for another cancer in the past five years - Your surgeon determines that pelvic lymph node removal cannot be safely performed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel 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.