Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer in Bogota Colombia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis
研究概览
简要总结
Prostate cancer is considered the fourth most common malignancy cancer in America. However, in Colombia the incidence is higher, and it is considered the second cause of death among men for malignance diseases. In the framework of clinical localized prostate cancer there is a controversy regarding the best predictors of risk and the best treatment options. The actual literature is discussing the possibility of underestimate the disease and actual tools are not sufficient for proper characterization. Is in this context that extended pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real commitment of the disease. The investigators need to know the characteristics that the disease has on the investigators community so the investigators can generate appropriate therapeutic approach. Thus, the present prospective observational-descriptive multicenter study, want to determine in three referral centers in Bogotá Colombia , the frequency of pelvic node involvement in patients with localized clinical prostate cancer from the stratification achieved by pelvic lymphadenectomy extended.
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 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical localized prostate cancer
- •Clinical stage: cT1-cT2-, N0-Nx, M0-Mx
- •Patients who undergo radical prostatectomy and extended lymphadenectomy in one of the 3 centers of reference.
排除标准
- •Patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.
结局指标
主要结局
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis
时间窗: within the first 30 days after surgery
After extended pelvic lymphadenectomy the nodes are classified in ilio-obturator nodes and internal iliaca nodes. Then those nodes are send to the pathology department of the each center, and by the histopathology analysis, the pathologist determine which nodes are compromised. With the histopathology result, the investigators report de nodal involvement.
次要结局
- The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.(Within the first 30 days after surgery)
研究者
Jose Gustavo Ramos
MD, Urology Resident
Javeriana University
