跳至主要内容
临床试验/NCT06741007
NCT06741007尚未招募不适用

Correlation of Pelvic Sentinel Lymph Node with Superficial Vein

Istanbul University0 个研究点目标入组 100 人开始时间: 2024年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally

研究概览

简要总结

Pelvic Sentinel Lymph Node (SLN) biopsy is an important integral part of endometrial surgery. Although SLN is usually found on internal iliac artery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac vessel locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of superior or deep uterine vein may determine the location of sentinel lymph node

详细描述

Endometrial cancer is the most common gynecologic cancer. 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.

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 agent is fluorescent indocyanine green (ICG). Although SLN is usually found on internal iliac artery during surgery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of right or left superior (SUV) or deep uterine vein (DUV), which actually are highly variable, may determine the location of sentinel lymph node.

So investigators aims to find any correlation between the location of SLN (obturator, external iliac and internal iliac) and the presence of SUV or DUV unilaterally or bilaterally.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •all women with early stage endometrial cancer who will be operated for staging

排除标准

  • •Previous radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)

研究组 & 干预措施

Single arm study using ICG as a sentinel lymph node agent in early stage endometrium cancer

Experimental

Single arm study using ICG as a sentinel lymph node agent to detect the location of SLN in correlation with the presence or absence of superficial or deep uterine vein in early stage endometrial cancer

干预措施: Retroperitoneal pelvic lymphatic and uterine vessel dissection (Procedure)

结局指标

主要结局

Detection rate and localisation of SLN in correlation with the presence or absence of uterine veins bilaterally

时间窗: Two years

The location of SLN ( obturator, external iliac and internal iliac) will be defined in percentages for each side of pelvis in relation to presence or absence of uterine vessels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Albayrak

Principal Investigator

Istanbul University

相似试验