Comparison of Short- and Long Term Clinical Outcomes of Patients With Stage IV Chronic Limb-threatening Ischemia and Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 836
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Colorectal cancer (CRC) and chronic limb-threatening ischemia (CLTI) are relatively frequent and potentially fatal diseases. However, studies that are comparing clinical outcomes between CRC and CLTI patients in more advanced stages of the disease are lacking. The study aim was to evaluate outcomes of patients with colorectal cancer liver metastases (CRLM) treated by curative-intent liver resection and CLTI patients according to wound, ischemia, foot infection (WIfI) classification by comparing the short- and long-term clinical outcomes.
详细描述
Peripheral arterial disease (PAD) is characterized by a global pandemic of growing proportions. In 2016, The Global Burden of Disease study reported that 202 million adults worldwide have PAD, with a higher prevalence compared to ischaemic heart disease (154 million), Alzheimer's disease (64 million) and cancer (43 million). The patient prognosis after PAD occurrence is poor because the disease often progresses to chronic limb-threatening ischemia (CLTI) that is an end-stage disease.
The 5-year mortality risk in CLTI patients is about 60%. When the mortality risk of CLTI is compared to mortality rates of the most common malignant diseases only six of them have a higher 5-year mortality rate compared to CLTI. One of them is colorectal cancer (CRC). CRC is the third most commonly occurring cancer in men and the second most commonly occurring cancer in women.
According to the latest CLTI treatment guidelines, the Society for Vascular Surgery (SVS) WIfI (wound, infection, ischemia) classification should be employed to stage limb condition in patients with CLTI that is analog to the use of tumor, nodes, metastases (TNM) cancer staging system. Recent data indicate that WIfI appears to correlate strongly with important clinical outcomes.
The annual incidence of CLTI is greater than the incidence of cancers characterized by high mortality rates (esophageal, stomach, brain and ovarian). In addition, more people die from CLTI each year compared to death rates of the already mentioned cancers. However, studies that are comparing clinical outcomes between cancer and CLTI patients in more advanced stages of the disease are lacking.
The study aim was to evaluate outcomes of the wound, ischemia, foot infection (WIfI) stage IV CLTI and colorectal cancer liver metastases (CRLM) patients managed by curative-intent liver resection by comparing the short- and long-term clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All chronic limb-threatening (CLTI) patients presenting with wound, ischemia, infection (WIfI) stage IV disease undergoing some revascularization procedure (endovascular, open surgery hybrid).
- •All colorectal carcinoma (CRC) patients undergoing colorectal liver metastasis (CRLM) surgery
排除标准
- •For CLTI group: patients who did not undergo revascularization surgery, those who underwent primary major amputation, patients with lower stages of the disease (stage I, II, and III), patients who had acute lower limb ischemia
- •For the CRLM group we excluded patients who did not undergo curative surgery, those who underwent liver resection due to other malignancies (hepatocellular carcinoma, cholangiocarcinoma, etc.), patients who underwent palliative surgery, liver transplantation
结局指标
主要结局
All-cause mortality
时间窗: up to 60 months
Number of participants who died from all causes of death in both chronic limb-threatening ischemia (CLTI) and colorectal liver metastasis (CLRM) population in a given time period
次要结局
- Short-term mortality(During the hospital stay (up to 30-days) and 30-day after the initial surgery)
- Hospital adverse event(During the patients hospital stay (up to 30-days))
研究者
Petar Zlatanovic
Principal Investigator
Clinical Centre of Serbia