Comparison of the resection site order in simultaneous approach of colorectal liver metastasis. An international multicentric retrospective trial (CORSICO Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Difference in overall morbidity rates between both approaches.
研究概览
简要总结
Treating colorectal cancer that has spread to the liver involves complex surgical decisions. When both the primary colorectal tumor and liver metastases are removed simultaneously, there is an ongoing debate about the best sequence in which these surgeries should be performed-whether to operate on the liver first (Primary Liver Stage) or the colon first (Primary Colon Stage). Different studies have reported varying outcomes for each approach, making it difficult to determine a universally preferred method.
The CORSICO study aims to determine whether the order of resection (removal of cancerous tissue) in a simultaneous surgery for colorectal cancer with liver metastasis affects post-surgery complications. It compares two approaches:
- Primary Liver Stage (PLS) – where the liver is operated on first.
- Primary Colon Stage (PCS) – where the colon is operated on first.
Objectives: The primary objective is to compare oncological outcomes, including overall survival, disease-free survival, and recurrence sites, between the two surgical the liver first (Primary Liver Stage) or the colon first (Primary Colon Stage) approaches
Study Type: Observational, multi-center, retrospective study.
Population: Patients who underwent simultaneous colorectal cancer and liver metastasis surgery from 2015 to June 2024.
Inclusion Criteria: Adults diagnosed with colorectal cancer and liver-only metastases who underwent simultaneous surgery.
Exclusion Criteria: Patients with extrahepatic metastasis, emergency surgeries, and incomplete records
Outcome Measures:
-
Primary Outcome: The primary outcome of study is to compare overall complication rates between Primary Liver Stage and Primary Colon Stage
-
Secondary Outcomes:
-
Compare surgery-related deaths and complications for both approaches.
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Analyze long-term survival and cancer recurrence rates.
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Evaluate outcomes for robotic vs. laparoscopic vs. open surgeries.
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Sample Size: 564 patients (256 in each group + 10% extra for potential dropouts).100 patients will be enrolled from TMH.
In this study, researchers will not conduct new procedures but will only analyze anonymized data that has already been collected from patient medical records. No additional tests or interventions will be performed on patients. Strict confidentiality measures will be in place, ensuring that personal information remains protected and is only accessible to the research team. The collected data will be securely transferred to the coordinating center, through a secure electronic system known as REDCap where it will be analyzed and used to generate results for publication, contributing to improved surgical strategies for colorectal cancer with liver metastases.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients with a diagnosis of colorectal cancer with synchronous liver metastasis between the referred period, who underwent simultaneous resection of primary tumor and hepatic metastasis.
排除标准
- •Emergency simultaneous resections
- •Proven extrahepatic metastatic disease at the time of diagnosis or at resection.
- •At least 10 cases performed by the invited center during the study period.
- •Incomplete records or less than 6 months of follow-up.
结局指标
主要结局
Difference in overall morbidity rates between both approaches.
时间窗: 90 days after surgery
次要结局
- Difference in mortality rates between both approaches.(90 days after surgery)
- Difference in morbidity associated to liver and morbidity associated to colon, between the approaches.(90 days after surgery)
- Difference in oncological outcomes between the two approaches.(1-year and at 5-years after surgery data)
- Difference in postoperative and oncological outcomes between the two approaches, when performed via laparoscopic or robotic surgery.(1-year and at 5-years after surgery data)
研究者
Dr Mahesh Goel
Tata Memorial Hospital