Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID07040657

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

Led by Dokuz Eylul University · Updated on 2025-06-27

100

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial studies lymph node mapping in patients newly diagnosed with stage I endometrial cancer undergoing surgery. It compares a standard 2-point cervical injection of methylene blue dye with a newer 4-point injection method to see if increasing injection sites improves sentinel lymph node (SLN) detection rates. The research aims to provide detailed insights into whether the 4-point injection offers an advantage for better mapping success. Participants are randomly assigned to one of two groups: one group receives injections at two cervix locations (3 and 9 o'clock), and the other group receives injections at four different cervix sites (2, 4, 8, and 10 o'clock). Both groups undergo the SLN mapping procedure using methylene blue dye to identify lymph nodes draining the uterus. This is a randomized controlled trial led by Dokuz Eylul University. During the study, researchers evaluate SLN detection rates, sensitivity and specificity of SLN biopsy for detecting metastases, and the rate of positive SLNs. They also monitor procedure duration, injection-related side effects, anatomical distribution of SLNs, and surgical complications. Participants are followed closely for one month to assess any complications and side effects related to the injection and surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with stage I endometrial cancer based on CT and PET-CT imaging
  • Pathologically confirmed diagnosis of stage I endometrial cancer
  • Female
  • Aged 18 to 75 years
Not Eligible

You will not qualify if you...

  • Diagnosed with dementia
  • Allergies to methylene blue or iodine
  • Received active treatment for another malignancy within the past 5 years
  • Unable to perform pelvic lymphadenectomy or history of prior pelvic lymphadenectomy
  • Multiple and confluent lymph nodes positive on FDG-PET/CT (not stage I)
  • Clinically or radiologically positive lymph nodes or metastatic disease
  • History of pelvic dissection and/or radiation therapy
  • Advanced cervical or uterine cancer
  • T3/T4 lesions
  • Cervical tumors larger than 2 cm
  • Hepatic dysfunction with MELD score ≥ 10 and creatinine ≥ 2.7 mg/dl

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo sentinel lymph node mapping using methylene blue injection into the cervix to identify lymph nodes draining the uterus. This involves either a 2-point or 4-point injection technique during surgery.

1 surgical procedure visit

Follow-up

Duration - 1 month

Participants are monitored for injection-related side effects and surgical complications after the procedure.

Follow-up visits as needed during 1 month post-procedure

Trial Site Locations

Total: 2 locations

1

Ankara University

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

2

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Actively Recruiting

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Research Team

I

Ibrahim Yalcin, MD

A

Ali Hakan Kula, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Comparison of tracer application methods for sentinel lymph node detection in open surgery patients with endometrial cancer: a retrospective cohort study.

Borek Sehnal, Petr Waldauf, Radoslav Matej...

https://pubmed.ncbi.nlm.nih.gov/40200256

Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations.

Robert W Holloway, Nadeem R Abu-Rustum, Floor J Backes...

https://pubmed.ncbi.nlm.nih.gov/28566221

Patient-reported outcomes after surgery for endometrial carcinoma: Prevalence of lower-extremity lymphedema after sentinel lymph node mapping versus lymphadenectomy.

Mario M Leitao, Qin C Zhou, Natalia R Gomez-Hidalgo...

https://pubmed.ncbi.nlm.nih.gov/31780238

Diagnostic accuracy of sentinel node biopsy in non-endometrioid, high-grade and/or deep myoinvasive endometrial cancer: A Turkish gynecologic oncology group study (TRSGO-SLN-006).

Duygu Altın, Salih Taşkın, Fırat Ortaç...

https://pubmed.ncbi.nlm.nih.gov/35033380

Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer.

Hitoshi Niikura, Michiko Kaiho-Sakuma, Hideki Tokunaga...

https://pubmed.ncbi.nlm.nih.gov/23988415

A study on uterine lymphatic anatomy for standardization of pelvic sentinel lymph node detection in endometrial cancer.

Barbara Geppert, Céline Lönnerfors, Michele Bollino...

https://pubmed.ncbi.nlm.nih.gov/28196672