Sentinel lymph node (SLN) biopsy is currently used in the management of vulvar and breast cancers as well as in malignant melanoma, and is being intensively studied in patients with cervical and endometrial cancers. The role of lymphadenectomy in the surgical management of early-stage endometrial cancer is still controversial. The main reason to perform a SLN biopsy is to detect the lymph node that will be the first involved with metastatic disease in the nodal basin. The SLN biopsy is performed after the SLN is located with the use of different tracers in a concept called SLN mapping. Moreover, SLN evaluation has been reported to improve the accuracy of lymph node staging due to SLN pathologic ultrastaging, which includes multiple serial sectioning and immunohistochemical assessment. The aim of this project is to conduct a multicentre, prospective, observational trial to compare two different SLN labelling methods (radioactive tracer with/without blue dye vs. indocyanine green-ICG) in the same patient and to evaluate the unilateral detection rate, sensitivity, number of detected SLN, anatomical localisation of detected SLN and bilateral detection rate of SLN. The main aim of the trial is the comparison of SLN mapping between two SLN labelling methods in the same patient. The trial will answer a question whether a combination of labelling methods in the same patient increase importantly the sensitivity of SLN biopsy. The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
83
The primary objective of this study is to compare SLN detection rate using two types of intracervical tracers (radioactive tracer with or without blue dye vs. ICG). The null hypothesis is that the detectionrate does not differ between the two techniques.
University Hospital Ostrava
Ostrava, Czechia
RECRUITINGCharles University-First Faculty of Medicine, University Hospital Bulovka, Department of Gynecology and Obstetrics
Prague, Czechia
RECRUITINGGynecologic Oncology Center, Department of Obstetrics and Gynecology; First Faculty of Medicine, Charles University of Prague and General Hospital in Prague
Prague, Czechia
RECRUITINGKNTB Zlin
Zlín, Czechia
RECRUITINGDepartment of Gynecology, Gynecologic Oncology and Endocrinological Gynecology, Medical University of Gdansk
Gdansk, Poland
RECRUITINGUniversity Medical centre Maribor, Department for Gynecologic and Breast Oncology
Maribor, Slovenia
RECRUITINGSLN unilateral detection rate
Number of hemipelvises where the SLN was found/number of all hemipelvises for each tracer and combination of tracers
Time frame: 2 years
Sensitivity of SLN biopsy for pelvic lymph node staging. Anatomical localisation of detected SLN
Number of true positive LN/(number of true positive LN+number of false negative LN) for each tracer and combination of tracers
Time frame: 2 years
Number of detected SLN.
Average number of detected SLN (in the specimen, labelled with the tracer, there might be one or more LN; the number of removed LN is one of the quality indicator).
Time frame: 2 years
Descriptive meassure: Anatomical localisation of detected SLN
Exact anatomical localisation of SLN (1-external iliac vessels, 2-internal iliac vessels, 3-obturator region, 4-paraaortic region, 5-presacral region).
Time frame: 2 years
Bilateral detection rate.
The number of patients with bilateral SLN detection/the number of all patients for each tracer and combination of tracers
Time frame: 2 years
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