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临床试验/NCT05164419
NCT05164419已完成不适用

Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques

Université de Sherbrooke0 个研究点目标入组 170 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
主要终点
Overall survival

研究概览

简要总结

We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.

详细描述

Main objective : evaluation the margin status (<1mm, 1-4mm, 5-9mm, >10mm) on the survival and recurrence in colo-rectal liver metastases surgery.

Secondary objectives include :

Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, TNM status of original tumor, timing between primary and metastasis, and extra-hepatic disease.

Methods :

A retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in groups according to their margin status. The local and distal recurrence rates are measured and well as survival. Data is obtained through our hospital data management system. Inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. Exclusion criterias include repeat liver resection, documented grossly positive margins (R2 resection), and unavailable pathologic information and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient is directly contacted. Data will is handled by the surgery resident responsible for the project as well as by research assistants. Statistical analysis are performed accordingly.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary colorectal cancer with liver metastasis
  • Undergone liver surgery at our center between 2011 and 2015
  • Pathological reports with margin status available (or specimen still available for measurement)

排除标准

  • Repeat liver resection No tissu or incomplete pathological information

结局指标

主要结局

Overall survival

时间窗: 2 years

Patient is dead or aline

次要结局

  • Local recurrence(2 years)
  • Distant recurrence(2 years)

研究者

申办方类型
Other
责任方
Sponsor

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