Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Surgical success rate, the rate of liver resection in each study arm
研究概览
简要总结
Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection
Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial
Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years
Primary investigator:
Per Sandstrom (Linköping)
Number of subjects 100 patients randomized in a 1:1 randomization
Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of < 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future
Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.
To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period.
In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a higher proportion of patients reaching R0.
Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization.
This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien grade 4 complication or higher (H0).
The ALPPS approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •By liver tumor board found accepted for inclusion
- •Patients with a tumor burden of colorectal liver metastasis
- •Signed informed content
- •Colorectal liver metastatic disease with an estimated FLR/sTLV of <30%
- •Primary tumor and any extrahepatic disease possible to resect in patients with liver first approach or after resection of primary tumor.
排除标准
- •Significant comorbidity rendering subjects unsuitable for major surgery
- •Progressive disease after preoperative oncological treatment
- •Age<18 years
结局指标
主要结局
Surgical success rate, the rate of liver resection in each study arm
时间窗: 8 weeks
For both the ALPPS and the portal vein embolization/ligation arm, resection is not allowed within the study if the patient is not reaching a future liver remnant of 30%. For both groups carcinomatosis or more metastases making aiming radical resections impossible will be seen as failures.
次要结局
- Liver growth rate(At one week after primary intervention)