Endometrial Cancer Stage I, Endometrial Neoplasms, Metastasis, Sentinel Lymph Node
Conditions
Keywords
endometrial neoplasm, methylene blue, metastasis, cervix
Brief 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.
Detailed 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.
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.
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Masking description
To minimize bias and ensure the reliability of study results, both participants and care providers will be blinded to group allocation. The surgeon administering the injection and the pathologist evaluating lymph node samples will not be informed whether the participant received the two-point or four-point cervical injection. This double-masking approach enhances the objectivity of care delivery and outcome assessment, thereby strengthening the validity of the findings.
Intervention model description
Randomized Controlled Trial (RCT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Positive SLNs Detected | 1 day | Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%)) |
| 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 (%)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | 1 day | Total time in minutes from injection to identification of sentinel lymph nodes (SLNs), recorded and compared between two-point and four-point cervical injection techniques. (Unit of Measure: Minutes) |
| Complications and Side Effects - Injection-Related Side Effects | 1 month | Incidence of side effects related to methylene blue injection (e.g., allergic reaction, local pain, or discoloration at the injection site), recorded during and after the procedure. (Unit of Measure: Number of events and proportion (%)) |
| SLN Anatomical Distribution | 1 day | Number and proportion of detected SLNs located in specific anatomical regions (e.g., pelvic, para-aortic) for each injection technique. (Unit of Measure: Number and Proportion (%)) |
| Surgical Complications | 1 month | Incidence of postoperative complications related to SLN mapping, including infection, hematoma, and lymphedema. (Unit of Measure: Number of events and proportion (%)) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactIbrahim Yalcin, MD
Backup ContactAli Hakan Kula, MD
Outcome results
None listed