A Retro-Prospective Observational Study on Causes, Characteristics, Intraoperative Management and Impact on Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative incidence of Metastases
研究概览
简要总结
The RUPTURE Project is a multi-center observational study aiming to understand tumor rupture during robotic partial nephrectomy (RAPN), a minimally invasive surgery used to treat kidney tumors. Tumor rupture-an unintended break of the tumor capsule during surgery-occurs in about 10-15% of cases but is poorly studied. This event may increase the risk of cancer recurrence or spread, but its true impact is still unclear.
The study includes adult patients who experienced a tumor rupture during RAPN. Researchers will collect data on patient and tumor characteristics, surgical techniques, how the rupture occurred and was managed, and long-term outcomes. Follow-up visits will monitor for recurrence, metastases, and survival for up to five years. No experimental treatments or extra procedures are involved; only standard care is followed.
By analyzing at least 100 cases from various hospitals, the study hopes to clarify whether tumor rupture affects prognosis and to identify risk factors and best practices for managing it. This could help improve patient safety, surgical strategies, and future clinical guidelines. All data are handled confidentially, and participation is voluntary.
详细描述
Background Robotic-assisted partial nephrectomy (RAPN) is a common, minimally invasive surgery used to remove kidney tumors while preserving healthy kidney tissue. While generally safe and effective, a complication called tumor rupture may occasionally occur. This means the tumor capsule (its outer layer) breaks during surgery, sometimes causing cancer cells to spill into the body. Although reported in up to 15% of surgeries, tumor rupture is not well understood, and its impact on long-term cancer outcomes remains unclear.
Purpose of the Study
This study, called the RUPTURE Project, aims to better understand tumor rupture during RAPN by answering key questions:
Does tumor rupture affect cancer recurrence or survival?
What causes it?
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who experienced tumor rupture during RAPN (referred to an unintended breach of the tumor capsule with or without spillage of malignant tissue during tumor resection)
- •Patients who provide informed consent to participate
- •Patients from 18 to 80 years of age.
排除标准
- •Patients undergoing radical nephrectomy or other nephron-sparing procedures.
- •Patients undergoing partial nephrectomy with other approaches (open, pure laparoscopic)
- •Patients with multiple ipsilateral tumors
- •Patients diagnosed with genetic abnormalities that increase the likelihood of developing renal cell carcinoma.
- •Patients who deny consent.
结局指标
主要结局
Cumulative incidence of Metastases
时间窗: From date of enrolment until the date of first documented event, assessed up to 60 months
cumulative incidence of tumor distant metastases
Cumulative incidence of All-cause Deaths
时间窗: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of non-cancer-related deaths (deaths due to other cause) disease). This will be evaluated through overall survival (OS)
cumulative incidence of recurrences
时间窗: From date of enrolment until the date of first documented event, assessed up to 60 months
cumulative incidence of tumor local recurrences (at surgery site)
Cumulative incidence of Cancer-related Deaths
时间窗: From date of enrolment until the date of first documented event, assessed up to 60 months
Cumulative incidence of cancer-related deaths (deaths due to the disease). This will be evaluated through cancer-specific survival (CSS)
次要结局
- Cause of rupture(During surgery)
- type of tumor rupture(During surgery)
- Surgical instrument causing the rupture(During surgery)
- Timing of tumor rupture(During surgery)