Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.
详细描述
Pelvic lymphadenectomy is associated with a significant risk of lower-limb lymphedema. In this study, we evaluate the feasibility of identifying the lower-limb drainage nodes (LLDNs) during pelvic lymphadenectomy for gynaecological cancers using an isotopic detection technique with a preoperative radiopharmaceutical injection into both feet Secondary objectives are to map lower-limb drainage, to assess the diagnostic value of our mapping technique, and to determine the incidence of lymphedema. LLDN mapping may allow the preservation of LLDNs, thereby decreasing the risk of lower-limb lymphedema and improving quality of life.
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
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
- •Female patients 18 years of age or older with indication of pelvic lymphadenectomy for gynaecological malignancy:
- •High risk endometrial cancer (stage IB type I grade 3, stage I type II, stage> IB) or with metastatic sentinel lymph node,
- •Early cervical cancer, or with metastatic sentinel lymph node,
- •Ovarian cancer.
- •Must provide her signed and informed consent
- •Beneficiary of a health insurance
- •Having received a medical examination
排除标准
- •Contraindication to pelvic lymphadenectomy
- •Presence of lymphedema of the lower limbs
- •Contraindication to radiomarkers (allergy or hypersensitivity to any component of the biomarker)
- •Patient with dementia or altered mental status
- •Pregnant or breast feeding patients
- •Participation in any other clinical trial that could interfere with the study results
结局指标
主要结局
Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.
时间窗: day of surgery
次要结局
- Percentage of patients with metastatic lower limb sampling(2 weeks after surgery)
- Anatomy of lower-limb drainage(day of surgery)
- Follow-up of patients to identify complications, and namely lower-limb lymphedema.(5 years)