RecruitingNot ApplicableNCT06163963

Sentinel Lymph Node in Early-Stage Endometrium Cancer

Sentinel Lymph Node Mapping with Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer


Sponsor

Istanbul University

Enrollment

100 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this prospective study is to investigate whether the detection rate of sentinel lymph node (SLN) with double tracer injected at two different sites may be increased compared to the standard use of a single tracer with single site (cervix) injection in early-stage endometrial cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • Must have preoperative histologic diagnosis of endometrial carcinoma
  • Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically
  • Must have written informed consent

Exclusion Criteria3

  • Possible allergic reaction to commonly used drugs
  • Medical or surgical contraindications for comphrensive staging
  • Preoperative or intraoperative findings of advanced endometrial cancer

Interventions

DIAGNOSTIC_TESTSentinel Lymph Node Mapping With Double Tracer and Double Injection Sites in Early-Stage Endometrium Cancer

This is a single arm interventional prospective study. Sentinel lymph node detection rate of the tracer injected in cervix (ICG- indocyanine green) before operation and the second tracer injected in uterine fundal subserosa (sterile charcoal black) at the start of operation are investigated. It is anticipated that additional tracer used in the uterine serosa may overcome the insufficiency (or increase the detection rate) of the standard single tracer injected in cervix for detection rate of sentinel lymph nodes, especially in paraaortic sentinel lymph nodes.

DIAGNOSTIC_TESTcharcoal injection to uterus to map sentinel lymph nodes

During surgery for endometrial cancer, charcoal injection to uterus to map sentinel lymph nodes in para aortic area besides the classic ınjection of indocyanine green for pelvic sentinel lymph node mapping.


Locations(1)

Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology

Istanbul, Istanbul / Turkey, Turkey (Türkiye)

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NCT06163963


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