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Sentinel Lymph Node in Early-Stage Endometrium Cancer

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163963
Enrollment
100
Registered
2023-12-11
Start date
2023-07-01
Completion date
2026-05-31
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Sentinel Lymph Node

Keywords

double tracer, endometrial cancer, sentinel lymph node

Brief 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.

Detailed description

Endometrial cancer is the most common gynecologic cancer. Although 85-90% of women are diagnosed at early stage, about 10-15% are diagnosed at advanced stages. Treatment and prognosis depends on the surgical staging of the apparently early stage disease including the evaluation of lymphatic status of the disease. Detection of positive lymph node upstages the apparently early stage endometrial cancer. However, systematic lymphadenectomy carries immediate and long term risks for patients including bleeding, massive transfusions, prolongation of operation time, serious major vessel and major abdominal organ injury and death. These risks are especially increased in para-aortic lymphadenectomy which is a part of staging procedure in apparently early stage endometrial cancer. Sentinel lymph node biopsy (SLNB) procedure is the biopsy of one or two lymph node(s) which represents the lymph node basin draining the area of malignancy. This biopsy may potentially eliminate the need systemic pelvic / para-aortic lymphadenectomy which harbours potential complications. Although SLNB became an standard procedure in endometrial cancer, available data on the SLNB in endometrial cancer is variable. The relevant literature suggests that the detection rate of sentinel lymph node using various tracer agents are between %70-98, even with lower for bilateral pelvic detection and para-aortic sentinel lymph node(s). The most commonly used tracer agents are methylene blue, radiolabeled colloid technetium 99 (Tc99), isosulfan blue and fluorescent indocyanine green. Although subserosal, intramyometrial uterine injections and peritumoral injections using hysteroscopy with different tracers and different detection rates have been used, cervical injection with ICG is the most favoured and standard technique with highest pelvic SLN detection rates. However, the para-aortic SLN detection rates are not satisfactory with a single tracer injected into cervix which may be critical especially in high grade endometrioid, serous and clear cell histological types. So, investigators aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer. Technically, 2 mL indocyanine green with sterile water is injected at 3 and 9 o'clocks (each 1 mL) of cervix before the start of laparoscopic operation. Additionally, 2-4 mL of sterile charcoal carbon black dye is carefully injected just beneath the serosal layer at uterine fundus bilaterally avoiding intravascular injection This is done classically during laparoscopy by a spinal needle introduced under optical supervision after all optical and operative instruments are entered. 10-15 minute interval is allowed before the start of harvesting sentinel lymph nodes in pelvic and paraaortic region.

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using double tracer compared to classic single tracer in early stage endometrial cancer. So, we aimed to investigate whether the sentinel lymph node detection rates may be improved with double tracer injected at two different sites (charcoal carbon black dye injected in subserosa and ICG injected into cervix) compared to standard single tracer injected in early-stage endometrial cancer, especially the para-aortic sentinel lymph nodes. Sterile charcoal carbon black dye is an agent previously used for sentinel lymph node detection in various cancers such as breast cancer. Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Must have preoperative histologic diagnosis of endometrial carcinoma 2. Must be in early stage ( stage1 and 2) endometrial carcinoma radiologically and clinically 3. Must have written informed consent

Exclusion criteria

1. Possible allergic reaction to commonly used drugs 2. Medical or surgical contraindications for comphrensive staging 3. Preoperative or intraoperative findings of advanced endometrial cancer

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of sentinel lymph nodes with double tracer in early stage endometrial carcinomaFrom the day of surgery to final pathology report (2 weeks)Detection rates of sentinel lymph nodes for both tracers in every pelvic and paraaortic lymph node basin are the primary outcome of the study.Sentinel lymph node detection rates of each region (pelvic, obturator, inframesenteric para-aortic, supra-mesenteric - infrarenal para-aortic), bilaterality/ unilaterality and staining with single or double tracer will be discussed compared to literature data.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMustafa ALBAYRAK, MD
mustafaalbayrak@icloud.com+905326871051
Backup ContactYagmur MİNARECİ, MD
yagmurminareci@gmail.com+905053574361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026