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临床试验/NCT06369480
NCT06369480招募中不适用

Prognostic Factors for Survival in Patients With Cholangiocarcinoma

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Aim I

研究概览

简要总结

The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field.

详细描述

BACKGROUND

Cholangiocarcinoma (CCA) is a highly aggressive neoplasia and is considered the second most common primary liver cancer (1). Its global mortality has shown an upward trend over the last two decades (2), with a survival rate of less than 5% at 5 years. The poor prognosis is related to late-stage detection since CCA can be asymptomatic in its early stages (3). In Denmark, the estimated cumulative risk of mortality due to CCA was 0.74 for men (ranking 20th in all of Europe) and 0.34 for women (ranking 6th in Europe) (4).

CCA is anatomically classified into three groups: intrahepatic, perihilar, and distal CCA (1,2). Additionally, CCA can be classified as mass-forming, periductal infiltrating, and intraductal based on tumor location, which may be associated with tumor morphology (3). A precise anatomical classification of CCA in each case is essential for accurately assessing potential complications (1).

The diagnosis, staging, and treatment of CCA can be challenging and are typically performed by a multidisciplinary team (MDT) of specialists. MDT meetings are a common practice in cancer care aimed at improving survival. However, it is important to note that there are currently no standardized recommendations for MDT practices in CCA (2). Recently, authors have made efforts to identify areas of improvement and establish standard guidelines for MDT decisions based on the current practices of specialized European teams with expertise in CCA. According to the recommendations of the European Network for the Study of Cholangiocarcinoma, international guidelines should be utilized for MDT decisions. However, preference for national guidelines should be given (2) Nevertheless, at the moment, there are not in Denmark a national guideline to determine the most optimal treatment for CCA patients based on local statistics.

Hence, the objective of this retrospective study was to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aimed to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients' eligibility for this study is contingent on a diagnosis of CCA confirmed by the MDT from Aalborg Universitetshospital, Aarhus Universitetshospital, Odense Universitetshospital, and Rigshospitalet in Denmark from 2013 to 2020.

排除标准

  • We will exclude from the analysis all records with more than one interventions. Additionally, all patients whose cholangiocarcinoma diagnosis was canceled following the MDT meeting will be also excluded, as well those with inconsistent data regarding date of reference to the MDT.

结局指标

主要结局

Aim I

时间窗: 6 months

Determine the survival rates of CCA patients based on various therapeutic approaches following the MDT decision.

Aim II

时间窗: 6 months

Determine the risk factors associated with unfavorable overall survival in CCA patients.

次要结局

未报告次要终点

研究者

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

Hans-Christian Pommergaard

Staff Specialist, Department of Surgery and Transplantation, Hepato - Pancreato - Biliary (HPB) team, Rigshospitalet, University of Copenhagen

Rigshospitalet, Denmark

研究点 (1)

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