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

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner) for endometriosis.

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.

It had two arms (groups): 2- Point Methylene Blue Injection (experimental) and 4- Point Methylene Blue Injection (active comparator).

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.

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.

The registry classes the interventions as procedure.

More on the Plan

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.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to women only aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Neither the endometriosis participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2025-05-01 with completion listed for 2026-05-01.

It ran at 2 sites in Turkey (Türkiye) (2).

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Sentinel Lymph Node (SLN) Detection Rate (time frame: 1 day). Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases (time frame: 1 day). Specificity of SLN Biopsy for Detecting Lymph Node Metastases (time frame: 1 day).

It also tracked 4 secondary outcomes, for example Procedure Duration, Complications and Side Effects - Injection-Related Side Effects, SLN Anatomical Distribution and Surgical Complications.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 100 people with endometriosis.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, Endometriosis research.