Multicentre Retrospective Study on Pancreas Resection for Colorectal Cancer Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The aim of this study is to collect data from different centres to obtain a larger case series and enable a better definition of the outcomes after pancreatic metastasectomy from primary colorectal cancer. To evaluate the possible benefits of surgery, we intend to retrospectively analyze the outcome of patients in whom pancreatic metastases have been surgically treated.
Primary objective;
- To evaluate feasibility and safety of pancreas resection in metastatic colorectal cancer
- To evaluate oncological outcome at six months from surgical procedure
Secondary objective:
- To evaluate oncological outcome at 12 months from surgical procedure
详细描述
Metastases to the Pancreas are quite rare and account for less than 5% of pancreatic malignancies diagnosed in living patients.
In autopsy cases of malignant tumours, the incidence of pancreatic secondary tumours reaches 15%.
The metastases are predominantly of epithelial origin, most commonly from lung, stomach, small bowel, colon-rectum, kidney , breast , liver , ovary ,melanoma and urinary bladder.
It is largely described that resection of isolated metastasis to the lung or liver from primary tumour leads to improved survival; yet there is no consensus about the benefit of pancreas resection for metastases and the gold standard treatment is still not well defined.
The lack of data for pancreas metastases resections depends on low incidence and high perioperative risks. However, the improvement in morbidity and mortality rates after pancreaticoduodenectomy made the indication for this operation acceptable.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated pancreatic metastases from Colorectal cancer
- •Previous surgery for colorectal cancer
- •Surgically manageable lesions: duodenal-pancreatectomy surgical removal of metastatic repetitions in pancreas
- •Other procedures:
- •total-pancreatectomy distal-pancreatectomy other metastases resection
- •R0 resection
- •no signs of peritoneal metastasis or tumor manifestations outside of the pancreas.
- •CT Scan before surgery
排除标准
- •metastases from different malignancies
- •other malignancies
- •surgically unmanageable lesions
- •Multiple synchronous colorectal metastasis
结局指标
主要结局
Disease free survival
时间窗: 6 months
disease free survival at 6 months
30-day morbidity
时间窗: 30 days
assessed by the number of patients with pancreatic resection who experienced any type of postoperative complication within 30-days from the surgical intervention
Overall survival
时间窗: 6 months
6 moths survival 3. Survival : 6 moths survival 4. Disease free survival at 6 months
30-day mortality
时间窗: 30 days
assessed by the number of patients with pancreas resection deceased within 30-days from the surgical intervention
次要结局
- Disease free survival (12)(12 months)
- Overall survival (12)(12 months)
研究者
Francesco Palmieri
MD, Principal investigator
Ospedale Generale Di Zona Moriggia-Pelascini