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临床试验/NCT04270851
NCT04270851Unknown不适用

Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability (The CoNoR Study)

University of Manchester1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Change in decision making on technical resectability

研究概览

简要总结

The CoNoR study aims to assess whether the use of the LiMAx test and the HepaT1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (CLM).

详细描述

The CoNoR Study will occur via 4 workstreams:

  1. Systematic review of all published criteria for colorectal liver metastases (CLM) technical resectability (systematic review protocol published on PROSPERO database: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=136748
  2. Expert interviews: Interviews with liver surgeons and radiologists to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools
  3. Online questionnaire: Online international questionnaire of liver surgeons to assess current standard practice in CLM technical resectability decision-making and role for novel assessment tools, in additional to identifying clinical scenarios in which these tools may be of greatest benefit
  4. Online case-based survey: Recruitment of 10-20 participants with 'difficult decisions' regarding technical resectability, and consent to use results from pre-operative assessments to create anonymised online case-based survey. Participants will consent to have two additional pre-operative assessments: the LiMAx tests and the HepaT1ca magnetic resonance scan. These results from these additional tests will also be used in the online survey, We will recruit international liver surgeons to complete this online survey, where they will be asked to provide an opinion on technical resectability for each individual case scenario, and to specify their operative plan, both before and after seeing the results of these novel assessment tools. We will assess for change in decision-making on resectability, and change in operative plan after seeing these test results. We will also assess for level of agreement between liver surgeons on each scenario, and identify where they difficult decisions persist.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 16 years of age with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases
  • Discussion at regional hepatobiliary multidisciplinary team meeting
  • Hepatobiliary surgical opinion that their case represents a potentially difficult decision regarding technical resectability
  • Ability to provide written informed consent

排除标准

  • Presence of a medical or psychiatric condition impairing the ability to give informed consent
  • Presence of any other serious uncontrolled medical condition
  • Patients under 16 years old
  • Contra-indications to magnetic resonance scanning

结局指标

主要结局

Change in decision making on technical resectability

时间窗: One year

Liver surgeons will view the standard pre-operative assessment results and decide if each case scenario is 'technically resectable.' They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and decide again. We will measure for any change in decision making after viewing the novel test results.

次要结局

  • Change in operative plan(One Year)
  • Level of agreement between liver surgeons on technical resectability(One Year)

研究者

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

Kat Parmar

Clinical Research Fellow

University of Manchester

研究点 (1)

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