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临床试验/NCT07717437
NCT07717437招募中不适用

DRAGON Registry - International Multicenter Registry and Medical Image Bank for Patients With Primarily Unresectable Liver Cancer or Liver Metastases That Underwent Combined Portal and Hepatic Vein Embolization (PVE/HVE) to Increase Future Liver Remnant Before Resection.

Maastricht University Medical Center31 个研究点 分布在 13 个国家目标入组 350 人开始时间: 2021年3月16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
350
试验地点
31
主要终点
Resectability three weeks after PVE/HVE and 5 years overall survival

研究概览

简要总结

The DRAGON registry aims to collect data on combined portal and hepatic vein embolization (PVE/HVE) for liver tumors, a technique expected to enhance liver regeneration compared to standard PVE. This collaborative registry focuses on identifying associations between baseline clinical/imaging parameters, clinical outcomes, and safety for patients undergoing PVE/HVE.

详细描述

Retrospective and prospective

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have undergone PVE/HVE or technical variations on this procedure
  • 18 Years and older
  • Men and women

排除标准

  • 未提供

结局指标

主要结局

Resectability three weeks after PVE/HVE and 5 years overall survival

时间窗: From enrolment until 5 year follow up

次要结局

  • Number of complications during embolization(Perioperative)
  • Clinical resection rates(Until MDT decision on resection (yes/no), approximately 3-6 weeks after the embolization)
  • Kinetic Growth Rate [%/week](3 weeks after the embolization)
  • Functional Growth Rate [%/week](Three weeks after the embolization)
  • 90-day survival after embolization(90 days post-embolization / post-resection)
  • Number of complications during surgery(Perioperative)
  • 90 day survival after resection(90 days)
  • Number of salvage procedures(Approximately 3-6 weeks after the embolization)
  • Number of participants with disease recurrence(Until five years after the embolization/resection)
  • Number of oncological interventions during follow up(Until five years after the embolization/resection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (31)

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