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NCT Number: NCT07040657

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

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.

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Key information

Conditions

Endometrial Neoplasms Endometrial Cancer Stage I Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Sentinel Lymph Node Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentinel Lymph Node Detection/Cervical Methylene Blue Injection

Procedure

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.

Primary outcomes

  1. Sentinel Lymph Node (SLN) Detection Rate

    Time frame: 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 (%))

  2. Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases

    Time frame: 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 (%))

  3. Specificity of SLN Biopsy for Detecting Lymph Node Metastases

    Time frame: 1 day

    Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis.

    (Unit of Measure: Percentage (%))

  4. Rate of Positive SLNs Detected

    Time frame: 1 day

    Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))

Secondary outcomes

  1. Procedure Duration

    Time frame: 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)

  2. Complications and Side Effects - Injection-Related Side Effects

    Time frame: 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 (%))

  3. SLN Anatomical Distribution

    Time frame: 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 (%))

  4. Surgical Complications

    Time frame: 1 month

    Incidence of postoperative complications related to SLN mapping, including infection, hematoma, and lymphedema. (Unit of Measure: Number of events and proportion (%))

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Hakan Kula, MD

CONTACT

[email protected]

+905358230685

Ibrahim Yalcin, MD

CONTACT

[email protected]

+90 505 265 60 24

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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