A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of Endoscopic Ultrasound-guided Laser Ablation for Liver Cancer by LaserPro Diode Laser System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Complete ablation rate
研究概览
简要总结
This trial is a prospective, single-arm, multi-center clinical trial. Four hospitals with national medical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive endoscopic ultrasound-guided laser ablation by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.
详细描述
The prospective, single-arm, multi-center clinical trial is to evaluate whether the endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System can achieve the safety and effectivenessof liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 69 subjects. Qualified participants will receive EUS-guided LA by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the complete ablation (CA) rate and the effective rate of EUS-guided LA by LaserPro Diode Laser System for liver cancer) and secondary outcomes (technical success rate, major complication rate, partial response rate, secondary ablation rate, progression-free survival (PFS), overall survival rate (OS), local tumor progression (LTP), distant tumor recurrence (DTR), quality of life score and alpha-fetoprotein levels). The one-month follow-up after the operation, three-phase MRI, liver function and tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, three-phase MRI of liver were examined every 2 to 3 months. After then, statistical comparisons of safety and effectivenessof the producedure will be made according to groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
- •Liver tumors within the scope of EUS scanning.
- •Single tumor≤ 3cm in diameter and the number of visible tumor were no more than
- •According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
- •Liver function: Child-Pugh A or B.
- •Age: 18-75 years old, regardless of gender.
- •Patients signed informed consent to participate in the trial.
排除标准
- •Contraindication for EUS or the target tumor were beyond the scope of EUS scanning.
- •Liver function: Child-pugh C, those could not improve after liver protective treatment.
- •Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding; platelet count less than 50×109/L, prothrombin time more than 30s or prothrombin activity less than 40%.
- •Severe failure of major organs such as kidney, heart, lung and brain.
- •Uncontrolled infection in any organ, especially inflammation of the biliary system.
- •Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.
结局指标
主要结局
Complete ablation rate
时间窗: 1 month
Defined as the absence of any contrast uptake within or at the periphery of the ablative zone. One month after either one session or multiple LA sessions, CTA was confirmed by contrast-enhanced MRI.
Effectiveness analysis
时间窗: 6 months
The effective rate of EUS-LA by LaserPro Diode Laser System for liver cancer was evaluated by mRECIST criteria.
次要结局
- Technical success rate(1 month)
- Major complication rate(6 months)
- Partial response rate(6 months)
- Overall survival rate (OS)(6 months)
- Quality of life score(6 months)
- Secondary ablation rate(6 months)
- Progression-free survival (PFS)(6 months)
- Local tumor progression (LTP)(6 months)
- Distant tumor recurrence (DTR)(6 months)
- Alpha-fetoprotein levels(6 months)