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临床试验/NCT03716414
NCT03716414已完成不适用

Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma

Fudan University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Performance Analysis

研究概览

简要总结

To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique could substitute the systematic Lymph node dissection(LND).

详细描述

Comprehensive surgical staging for endometrial carcinoma(EC) is an indisputable staging and prognostic tool. The staging procedure includes total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy, omental biopsy if necessary. Since lymph node metastasis is one of the most important risk factors of prognosis. The dissection of lymph nodes has been used for staging, prognostic information, and to determine the need for adjuvant therapy. The approach to lymph node evaluation in women with EC is still a subject of debate. Practice varies across different institutions or surgeons. In general, the options for management of retroperitoneal lymph nodes include no lymph node dissection (LND), systematic LND only if the risk of lymph node metastasis exceeds a certain threshold, or routine sentinel LND following lymphatic mapping. lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, moreover, there is lack of evidence of a therapeutic benefit of LND, less invasive techniques have emerged as possible alternatives. The technique for lymphatic mapping and sentinel lymph node dissection (SLND) in EC has been refined and found a low false-negative rate for detection of positive lymph nodes. The 2018 National Comprehensive cancer Network (NCCN) guideline of uterus cancer states SLN mapping can be considered for the surgical staging of apparent uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at exploration. It indicates low-risk patients could avoid those side effects of the systematic Lymph node dissection. Whether high-risk patients (grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion) can be benefited from this technique? This prospective cohort study is designed to To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma. Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18~100 years.
  • No contraindication to surgery.
  • Signed and dated informed consent.
  • high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations).
  • With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT.

排除标准

  • Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter < 2cm (in intraoperative frozen section examinations).
  • Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).

结局指标

主要结局

Performance Analysis

时间窗: Within 14 days after the surgery

Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.

次要结局

  • 5-year survival rate(5 years after the surgery)
  • Recurrence rate(5 years after the surgery)
  • Adjuvant therapy rate(5 years after the surgery)
  • Postoperative complications(1 years after the surgery)

研究者

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

Xiaojun Chen

Principal Investigator

Fudan University

研究点 (1)

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