Overview
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.
Description
In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
Eligibility
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.