跳至主要内容
临床试验/NCT07272928
NCT07272928招募中不适用

Comparison of the Resection Site Order in Simultaneous Approach of Colorectal Liver Metastasis. An International Multicentric Retrospective Trial.

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Difference in overall morbidity rates

研究概览

简要总结

Colorectal cancer frequently presents with liver metastases, and complete removal of both primary and liver tumors can significantly improve survival. Simultaneous resection (SA) of the colon and liver is increasingly used and is considered safe when minor liver resections are performed, offering advantages such as shorter hospitalization, fewer complications, and faster chemotherapy initiation.

However, the best sequence of resection, liver-first or colon-first, remains uncertain, as each has potential benefits and drawbacks, particularly regarding anastomotic healing. Minimally invasive approaches to SA show similar outcomes to open surgery, though limited data suggest that resection order may affect blood loss.

详细描述

Colorectal cancer is the third most common cancer worldwide, and 15-25% of patients present with liver metastases at diagnosis. Complete resection of both the primary tumor and liver metastases can yield survival rates up to 47.9%. Simultaneous resection (SA) of the colon and liver is a potential option for patients with synchronous metastases, though traditionally considered high-risk, especially when major hepatectomies are involved.

Recent studies show that SA is safe when minor hepatectomies are paired with standard colon resections and may offer advantages such as reduced hospital stay, lower costs, fewer complications, and faster initiation of chemotherapy.

The optimal sequence of resection in SA remains unclear. Liver-first procedures may preserve sterility and address the prognostically significant lesion first but could impair bowel anastomosis healing.

Minimally invasive surgery (MIS), including laparoscopic and robotic approaches, is increasingly used for SA and appears comparable to open surgery in terms of morbidity, mortality, and oncologic outcomes. Early data on MIS suggest that resection order may influence intraoperative blood loss, but findings remain inconsistent and require further investigation.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Adult patients diagnosed with colorectal cancer with synchronous liver metastases during the reference period, who underwent simultaneous resection.

排除标准

  • Simultaneous emergency resection due to symptoms of the primary tumor.
  • Presence of extrahepatic metastatic disease confirmed at the time of resection or diagnosis.
  • High surgical risk defined as an ASA risk score greater than
  • At least 10 cases performed by the invited center during the study period.
  • Incomplete data or follow-up of less than 6 months.

结局指标

主要结局

Difference in overall morbidity rates

时间窗: Through study completion, an average of 1 year

Measurement of the difference in overall morbidity rates between both approaches (liver first vs. colon first) in colorectal cancer with liver metastasis influences postoperative

次要结局

  • Overall survival(Through study completion, an average of 1 year)
  • Mortality(Through study completion, an average of 1 year)
  • Disease-free survival(Through study completion, an average of 1 year)
  • Recurrence sites(Through study completion, an average of 1 year)
  • Morbidity(Through study completion, an average of 1 year)

研究者

发起方
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
申办方类型
Other
责任方
Sponsor

研究点 (1)

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