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临床试验/NCT01526200
NCT01526200已完成不适用

Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases

University of Milan1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography

研究概览

简要总结

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) has become a part of clinical practice. However, if it should be selectively or routinely applied remains unclear. This study is carried out to clarify which are the criteria for a selective use of CE-IOUS if any.

详细描述

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) is entered in clinical practice. However, its impact seems to decrease with the improvement of preoperative imaging. Therefore, if CE-IOUS should be selectively or routinely applied remains unclear: a profile of patients who may benefit of CE-IOUS application has to be disclosed. The aim of this study is to define reliable criteria for a selective use of CE-IOUS during surgery for CLM. IOUS is performed using 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging is completed by CE-IOUS using the standard 3-6 MHz convex probe and the dedicated 1.88-3.76 MHz harmonic frequency probe. In all patients, 2.4 mL of sulphur-hexafluoride microbubbles (SonoVue®, Bracco, Milan, Italy) are injected through a peripheral vein by the anesthesiologist. Ultrasound guidance is used to drive the dissection plane as previously described. Reference standards are histology and imaging at 6 months after surgery. Univariate and multivariate analyses are performed. Statistical significance is set at P=0.05.

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
29 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.
  • each patient had at least 6 months of postoperative follow-up.

排除标准

  • patients who after IOUS and CE-IOUS had explorative laparotomy only were excluded from the analysis since there was no histological confirmation of the tumor and most of them were lost to surgical follow-up

结局指标

主要结局

new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography

时间窗: October 2007 - March 2011 (up to 4 years)

次要结局

  • new colorectal liver metastases detected at intraoperative ultrasonography(October 2007 - March 2011 (up to 4 years))
  • new colorectal liver metastases detected during 6-month postoperative follow-up(October 2007 - December 2011 (up to 4 years))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Guido Torzilli

Professor of Surgery, MD, PhD

University of Milan

研究点 (1)

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