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临床试验/NCT05927818
NCT05927818招募中不适用

Efficacy of Sentinel Lymph Node Biopsy in Early-Stage Ovarian Cancer

Istanbul University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Efficacy of sentinel lymph node biopsy in highly suspicious adnexal masses for early-stage ovarian cancer

研究概览

简要总结

The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing it to the results obtained from systematic lymphadenectomy, each performed in participants with a suspicious adnexal mass for early-stage ovarian cancer.

详细描述

Ovarian cancer is the leading cause of mortality among gynecologic cancers. Although most women are diagnosed at advanced stage, about 20% are can be diagnosed at an earlier stage. Treatment and prognosis depends on the correct assessment of stage of the apparently early stage (Stage I and II). About 10-30% of apparently early stage ovarian cancer patients are upstaged based on the final pathology report. Detection of positive lymph node is an important contributor for upstaging of apparently early stage ovarian 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 paraaortic lymphadenectomy which is an integral part of staging procedure in early ovarian 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 / paraaortic lymphadenectomy. Although SLNB became an integral and accepted procedure in endometrium and cervix cancers, available data on the SLNB for ovarian cancer is limited and is in its infancy to be incorporated in routine practice of ovarian cancer surgery.

So, investigators aim to compare the effectiveness of SLNB procedure results with systematic lymphadenectomy, both performed in each participant, either by laparotomy or laparoscopy.

Technically, 2-4 mL of sterile black carbon stain is carefully injected beneath the adnexal mass just under peritoneal covering of mesovarium or infundibulopelvic ligament avoiding intravascular injection before removal of suspicious adnexal mass for frozen section. This is done classically through a laparotomy incision but can also be performed laparoscopically via a needle introduced transcutaneously into the base of adnexa under optical supervision. 10-15 minute interval is allowed before resection of adnexal mass for frozen section. A peritoneal incision and pelvic and paraaortic retroperitoneal dissection is carried out for identification of major vessels and important surgical landmarks (abdominal ureters, gonadal vessels, inferior mesenteric artery and etc.) up to the left renal vein to visually detect the sentinel lymph node(s) stained in black. Lymphatic vessels are carefully eliminated visually not to be biopsied instead of sentinel lymph node. An additional 2 mL injection is allowed if a SLN could not be detected before systematic lymphadenectomy, adnexectomy and other surgical staging procedures. Frozen section of a adnexal mass is carried out thereafter following the detection and biopsy of SLN. Systematic lymphadenectomy is abandoned in case of a non-malignant frozen section result.

研究设计

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

盲法说明

No party in our clinical trial are prevented from having knowledge of the interventions assigned to individual participants.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Must have a suspicious adnexal mass for early stage ovarian cancer
  • Must be medically and surgically fit enough to perform SLNB and complete the systematic lymphadenectomy.

排除标准

  • Ovarian mass with low probability for early stage ovarian cancer.
  • Medical or surgical contraindications for surgical comprehensive staging.
  • Metastatic cancers or double primary cancers (metachronous) of ovary
  • Recurrent ovarian cancer
  • Preoperative or intraoperative finding of advanced ovarian cancer (FİGO stage III and IV)
  • Neoadjuvant ovarian cancer

结局指标

主要结局

Efficacy of sentinel lymph node biopsy in highly suspicious adnexal masses for early-stage ovarian cancer

时间窗: From the day of surgery to final pathology report (two weeks)

Sensitivity, specificity, positive and negative predictive value for sentinel lymph biopsy results (compared to lymph nodes collected by systemic lenfadenopathy) will be calculated. These calculations will be expressed in percentages and will be compared using appropriate statistical method.

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

MD, Gynecologic Oncology Fellow

Istanbul University

研究点 (2)

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