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

June 18, 2025 updated by: İbrahim Yalçın, Dokuz Eylul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Ankara University
        • Contact:
          • Salih Taskin, MD
          • Phone Number: +905064383629
        • Principal Investigator:
          • Salih Taskin, MD
      • İzmir, Turkey
        • Recruiting
        • Dokuz Eylul University
        • Contact:
        • Sub-Investigator:
          • Ali Hakan Kula, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2- Point Methylene Blue Injection

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
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.
Active Comparator: 4- Point 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (%))
1 day
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 (%))
1 day
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 (%))
1 day
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 (%))
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day
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 (%))
1 month
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 (%))
1 day
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 (%))
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 5, 2025

First Submitted That Met QC Criteria

June 18, 2025

First Posted (Actual)

June 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 693-SBKAEK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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