Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (Study LIVERaTION)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Local recurrence
研究概览
简要总结
Radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. Due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. Till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. On the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. However, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin.
The investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. Therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •18 year of age or older.
- •WHO performance scale 0-2
- •Consecutive patients (both sexes equally distributed) suffering from CRLM confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation or patients suffering from HCC.
- •Any previous chemotherapy regime is permitted.
- •ASA score 1 to 3.
排除标准
- •Previous or concurrent cancer that is distinct from one primary tumor of which the Liver metastasis comes from EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1).
- •Any cancer curatively treated > 3 years prior to enrollment is permitted.
- •Non-resectable extrahepatic metastases.
- •Liver metastasis from other origin apart from colorectal.
- •Bening primary tumor of the liver.
- •Pregnant woman.
- •Participation in another clinical trial.
研究组 & 干预措施
Arm 1: Control
In this arm it will be permitted one/several conventional methods according to surgeon preference:
- Conventional crusch-clamp or finger fracture technique
- Ultrasonic dissector (CUSA, SONOK..) or Ultrasonic mediated devices
- Water jet dissector
- Argon beam coagulator
Arm 2: study arm
In this arm it will be permitted to use the radiofrequency devices which have demonstrated evidence in the literature in terms of reducing local recurrence alone or in combination with any conventional method described previously in Arm. (Coolingbis device by VecMedical as well as Aquamantys (Medtronic) These devices and their operating procedure have been described in detail elsewhere Briefly, it consists of a handheld instrument that might be employed not only for margin coagulation but also as hemostatic instrument. After performing the hepatectomy the bladeless part of the device should be applied onto the surgical margin following the protocol 3-4 s/cm2 of liver transection surface at maximum power output.in order to perform an additional margin coagulation
干预措施: Additional margin coagulation (Procedure)
结局指标
主要结局
Local recurrence
时间窗: 5 years follow-up
Local recurrence (LR): defined as any growing or enhancing tumour in the margin of hepatic resection specifically reviewed to this aim in a later follow-up imaging
次要结局
- overall survival (OS)(From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months)
- Disease free survival (DFS)(2 years of follow-up)
- Cancer specific survival (CSS)(From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months)
- Postoperative complications(90 days after surgery)
- Hepatic recurrence(From the surgery to hepatic recurrence or lost of follow-up whichever came first, assessed up to 24 months)
研究者
Patricia Sanchez Velazquez
Principal Investigator
Hospital del Mar