NCT02728167终止不适用
Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Normalized blood loss (ml/cm2)
研究概览
简要总结
The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years at the day of consenting to the study.
- •Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.
- •ECOG PS ≤
- •Adequate bone marrow and liver function at baseline as defined below:
- •Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),
- •Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.
- •Recovered from prior anti-neoplasic treatment-related toxicity (grade <2 persistent treatment-related toxicity as per CTCAE v4 are accepted).
- •Willingness for follow-up visits.
- •Covered by a medical insurance.
- •Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
排除标准
- •Patients having previously undergone
- •a major hepatic surgery (i.e. more than 3 liver segments) or
- •biliary major surgery.
- •Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.
- •Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
研究组 & 干预措施
Pre-coagulation by HIFU-AR
Experimental
Pre-coagulation of the liver parenchyma with HIFU and standard liver resection
干预措施: Pre-coagulation of the liver parenchyma with HIFU (Device)
Standard liver resection
No Intervention
Standard liver resection
结局指标
主要结局
Normalized blood loss (ml/cm2)
时间窗: During hepatectomy
To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection
次要结局
- Hemostasis time(During hepatectomy)
- Total blood los (ml)(During hepatectomy)
- Transection time(During hepatectomy)
- Transection time/cm2 of liver area (min/cm2)(During hepatectomy)
- Rate of Pringle manoeuvre(During hepatectomy)
- Length of hospital stay(10 days)
- Number of patients with postoperative complications assessed using Dindo-Clavien classification(6 months)
- Clip density on the liver section area(During hepatectomy)
- Rate of patients needing a blood transfusion(During hepatectomy)
研究者
研究点 (2)
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