Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue

Not Applicable

Recruiting

• Conditions: Endometrial Neoplasms; Sentinel Lymph Node; Endometrial Cancer Stage I; Metastasis

• Registration Number: NCT07040657
• Lead Sponsor: Dokuz Eylul University

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.

Study Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Primary Completion: 2026-05-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 (%))

Trial Locations

Locations (2)

Ankara University; 🇹🇷 Ankara, Turkey

Dokuz Eylul University; 🇹🇷 İzmir, Turkey