An interventional study of Sentinel Lymph Node Detection/Cervical Methylene Blue Injection in Endometrial Neoplasms, Endometrial Cancer Stage I and Sentinel Lymph Node, sponsored by Dokuz Eylul University. Recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Diagnostic
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.
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medical Conditions
Cancer-Related Conditions
Organ Dysfunction
In the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 3 o'clock position At the 9 o'clock position
Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
In the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position
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.
Sentinel Lymph Node (SLN) Detection Rate
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 (%))
Time frame: 1 day
Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases
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 (%))
Time frame: 1 day
Specificity of SLN Biopsy for Detecting Lymph Node Metastases
Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis. (Unit of Measure: Percentage (%))
Time frame: 1 day
Rate of Positive SLNs Detected
Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))
Time frame: 1 day
Procedure Duration
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)
Time frame: 1 day
Complications and Side Effects - Injection-Related Side Effects
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 (%))
Time frame: 1 month
SLN Anatomical Distribution
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 (%))
Time frame: 1 day
Surgical Complications
Incidence of postoperative complications related to SLN mapping, including infection, hematoma, and lymphedema. (Unit of Measure: Number of events and proportion (%))
Time frame: 1 month
Plan to share: Yes — De-identified IPD related to the primary and secondary outcomes will be shared upon reasonable request. Access will be granted for academic and scientific research purposes, subject to approval by the study investigators and compliance with ethical and regulatory guidelines. A data-sharing agreement will be required to ensure proper use and confidentiality of the data.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Dokuz Eylul University