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/40200256Actively Recruiting
Led by Dokuz Eylul University · Updated on 2025-06-27
100
Participants Needed
2
Research Sites
26 weeks
Total Duration
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
Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Total: 2 locations
1
Ankara University
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
2
Dokuz Eylul University
Izmir, Turkey (Türkiye)
Actively Recruiting
I
Ibrahim Yalcin, MD
A
Ali Hakan Kula, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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