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临床试验/NCT06673511
NCT06673511尚未招募不适用

A Single-Arm, Open, Multicenter, Exploratory Clinical Study on the Application of Sentinel Lymph Node Mapping Mechnique in the Surgery of Early Epithelial Ovarian Cancer

Anhui Provincial Hospital0 个研究点目标入组 246 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
246
主要终点
PFS

研究概览

简要总结

This study is a single-arm, open, multicenter, exploratory clinical study to evaluate the feasibility, sensitivity, and specificity of sentinel lymph node (SLN) mapping technology in the population with early epithelial ovarian cancer in China. Patients with stage I-II epithelial ovarian cancer evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning) are selected as the study population. The feasibility and value of SLN mapping technology in early epithelial ovarian cancer are explored through the location and number of sentinel lymph nodes, lymph node metastasis rate, 3-year disease-free survival rate, and the incidence of postoperative lower limb edema. The study plans to recruit 246 subjects. All subjects will receive study treatment after signing the informed consent form and passing the screening.

详细描述

This clinical study is an evaluation of surgical method improvement. The standard surgical procedure includes: selecting patients who meet the inclusion criteria, completing preoperative examinations, having thorough preoperative communication, determining laparoscopic surgery and open surgery according to the patient's condition and examinations, mainly using open surgery and strictly screening laparoscopic surgery; carefully exploring the pelvic and abdominal peritoneum and the surface of abdominal organs during the operation, evaluating whether there is lymph node enlargement in the retroperitoneum, taking ascites or peritoneal lavage fluid, after removing the patient's adnexa, sending it for rapid pathology. After the pathology is confirmed to be epithelial cancer, select a fine needle to inject 2 ml of ICG (1.25 mg/ml) respectively into the residual end of the suspensory ligament and proper ligament of the affected side. If there are lesions on both adnexa, inject on both sides; open the retroperitoneum and open the peritoneum upward to reach the level of the left renal vein; observe the lymphatic drainage area, separate the lymph and adipose tissue along the blood vessels, and look for the visualized lymph nodes; send the resected visualized lymph nodes for intraoperative rapid pathology; after resecting the visualized sentinel lymph nodes, perform systematic lymph node resection (including the para-aortic lymph nodes below the left renal vein and bilateral pelvic lymph nodes); resect the greater omentum, perform biopsy and/or resect any suspicious lesions, and perform random biopsy of normal peritoneum; resect the total uterus and suture the vaginal stump; conduct postoperative follow-up and collect statistics.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Epithelial ovarian cancer evaluated as stage I-II by preoperative imaging (enhanced CT and/or magnetic resonance scanning), without retroperitoneal lymph node enlargement or with lymph node enlargement having a short diameter less than 1 cm.
  • Age between 18 and 75 years old (≥18 and ≤75).
  • ECOG score: 0 -
  • Patients with appropriate bone marrow hematopoiesis function, renal function and liver function: white blood cell count > 3.0 x 109 cells/L; platelet count > 100 x 109/L; creatinine < 180 μmol/L; bilirubin < 1.5 times normal; aspartate aminotransferase/alanine aminotransferase < 3 times normal.
  • No fertility requirement.
  • Have signed the informed consent form.

排除标准

  • Advanced epithelial ovarian cancer or retroperitoneal lymph node metastasis evaluated by preoperative imaging (enhanced CT and/or magnetic resonance scanning).
  • Previous history of resection or sampling of para-aortic and/or iliac vascular lymph nodes.
  • Previous history of abdominal aorta and/or iliac vascular surgery.
  • Previous allergy to indocyanine green or iodine.
  • Previous history of abdominal radiotherapy.
  • Pregnant and lactating patients.
  • Those who refuse to sign the informed consent form.
  • Those who are considered by the investigator as inappropriate to participate in this trial.

结局指标

主要结局

PFS

时间窗: three years

Progression-Free Survival (PFS) is defined as the time interval between the patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.

次要结局

  • OS(three years)

研究者

发起方
Anhui Provincial Hospital
申办方类型
Other Gov
责任方
Sponsor

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