Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- 90-day complication rate and severity
研究概览
简要总结
The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts.
详细描述
Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other established liver directed therapies.
Prior to inclusion all potential participant will be evaluated by the local multidisciplinary team, to insure fulfillment of the above-mentioned criteria. In general, the included patient will have tumors with <1 cm of margin to major hepatic vessels or bile ducts, thereby not allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract damage, liver failure or ineffective ablation due to heat sink.
IRE will be done under general anesthesia as an in-patient procedure. Patients will be observed for at least 24 hours after IRE.
Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up period, patients will be asked to fill out electronic forms monitoring pain, quality of life and nutritional status. After 24 months the patients will only be followed with CT scans in accordance with the mentioned schedule. Data collection for scientific purposes will stop when the last included patient has been followed for at least 24 months or when the study period concludes.
In case of multiple liver tumors, where a conventional treatment approach is not possible due to a single lesion being too close to major vessels or bile ducts, IRE may be used in conjunction to conventional therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary cancer of the liver.
- •Largest tumor diameter ≤5 cm in any plane.
- •Tumor must be deemed as unresectable and unsuitable for other established curative liver directed therapies.
- •Treatment must be given with curative intent.
- •Patients must be able to give informed consent.
排除标准
- •Radiological signs of synchronous intra- or extrahepatic disease, unless curative intended therapy is planned.
- •Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound)
- •American Society of Anesthesiologists (ASA) score >3
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Child-Pugh class C
- •International Normalized Ratio (INR)>1.5
- •Pregnancy
- •Persistent atrial fibrillation
- •Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators.
- •Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE)
- •Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
- •Patient is referred from a hospital outside of Denmark
结局指标
主要结局
90-day complication rate and severity
时间窗: 90 days after intervention (last patient)
Adverse events will be registered and scaled according to the Clavien-Dindo classification.
次要结局
- Median overall survival (OS) from IRE(2 years after intervention (last patient))
- Median local progression free survival from IRE(2 years after intervention (last patient))
- Technical success rate(90 days after intervention (last patient))
- Technical efficacy rate (1 month) (according to SIR)(90 days after intervention (last patient))
- Longitudinal changes in perceived quality of life(2 years after intervention (last patient))
- Longitudinal changes in pain perception(2 years after intervention (last patient))
- Periprocedural pain perception(90 days after intervention (last patient))
- Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status(2 years after intervention (last patient))
- Longitudinal changes in nutritional status assessment(2 years after intervention (last patient))
研究者
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Professor of surgery, Consultant surgeon, DMSc
Aalborg University Hospital