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临床试验/NCT04683783
NCT04683783已完成不适用

RENACI Project: National Registry of Liver First Approach

Hospital Miguel Servet1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
1
主要终点
Percentage of patients who complete the entire cycle

研究概览

简要总结

Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.

详细描述

Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. However, due to the comorbidity or extent of the tumor disease, only a minority of patients are candidates for curative resections. When surgical treatment is indicated, different strategies can be used. In the classic strategy, the primary tumor is resected first, followed by surgery for metastases and, after that, adjuvant chemotherapy. More recently, simultaneous resection of primary and liver lesions has been used, mainly for limited liver disease without the need for large-volume liver resections. A third option is preoperative chemotherapy, followed by resection of liver metastases and surgery of the primary tumor in a second stage. This technique was initially described in 2006 by Mentha for patients with asymptomatic rectal tumors with initially unresectable or borderline resectable liver metastases. These patients were treated with neoadjuvant chemotherapy, followed by surgery for liver metastases, chemo/radiotherapy of the primary tumor, and second stage surgery. This is what is called surgery or reverse strategy (liver first approach in the Anglo-Saxon world). This strategy has the potential advantage of allowing resection of advanced liver disease in patients when the primary tumor is asymptomatic. Advanced liver disease is the leading cause of mortality in these patients. Subsequently, this strategy has been used in colorectal tumors of any location with synchronous metastases. No clear advantage or disadvantage has been demonstrated with any of the three strategies in terms of long-term survival. There is also no prospective randomized clinical trial comparing classical with reverse strategy.

Most of the previous studies that evaluated this strategy only included patients with liver resection, not the primary one. Therefore, there is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy. The potential advantage of this strategy is the possibility of rescuing more patients with colorectal cancer liver metastases, thus increasing survival.

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
All
接受健康志愿者

入选标准

  • Patients ≥ 18 year old.
  • Scheduled surgery for colorectal cancer with synchronous liver metastases using the liver first approach.
  • ASA score I-III.
  • They have signed the informed consent.

排除标准

  • Patients under 18 year old.
  • ASA ≥ IV.
  • Urgent surgery.
  • Patients who have not signed the informed consent.

结局指标

主要结局

Percentage of patients who complete the entire cycle

时间窗: 90 days

Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor

次要结局

  • Mortality rate(90 days)
  • Morbidity rate(90 days)

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Serradilla, MD, FACS

MD, FACS

Hospital Miguel Servet

研究点 (1)

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