Italian Group of Regenerative and Occlusive Worldwide-used Techniques of Hepatic Hypertrophy - IGROWtoh
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
- compare the techniques used in terms of function and volumetric hypertrophy
研究概览
简要总结
The goal of this national mutlticenter observational study is to learn and describe trends over time in the use of techniques for inducing hepatic hypertrophy in Italy. Patients will be treated according to the current clinical practice of the participating centers and will be observed from the moment of recruitment and throughout their stay. Information on vital status will be collected, as far as possible, for up to 5 years after surgery in order to record any events that occur in a timely manner. There are also plans to retrospectively collect data on patients who underwent hypertrophic techniques in the previous 10 years, in order to establish a historical cohort for each center that can be used for comparison with the prospective cohort.
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
- 否
入选标准
- •Patients aged 18 or older
- •Obtaining informed consent
- •Patients with liver neoplasia (benign or malignant) and with a future liver remnant volume deemed insufficient (<20%-40%) by the local multidisciplinary team
排除标准
- •pregnant or breastfeeding woman
研究组 & 干预措施
Retrospective Cohort
There is also a plan to collect data on patients who underwent hypertrophic techniques in the previous 10 years, in order to establish a historical cohort for each center that can be used for comparison with the prospective cohort.
Prospective cohort
The clinical information from prospectice cohort will be collected from the moment of recruitment , as far as possible, for up to 5 years after surgery in order to record any events that occur in a timely manner.
结局指标
主要结局
compare the techniques used in terms of function and volumetric hypertrophy
时间窗: through study completion, an average of 1 year
compare the techniques used in terms of drop-out
时间窗: through study completion, an average of 1 year
Describe the temporal trends in the use of techniques for inducing hepatic hypertrophy in Italy
时间窗: through study completion, an average of 1 year
compare the techniques used in terms of 90-day mortality
时间窗: through study completion, an average of 1 year
compare the techniques used in terms of long-term survival
时间窗: through study completion, an average of 1 year
compare the techniques used in terms of disease-free survival
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点