NCT01785082已完成3 期
Prospective, Randomized, Controlled, Multi-centric, Phase III Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 4
- 主要终点
- number of correctly determined positive patients in each trial group
研究概览
简要总结
The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection. The LiMAx-test is compared with an untreated control group and post-surgical management of both groups is investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •male or female patients of 18 years or older which are able to give informed consent with indication for surgical partial liver resection according to OPS code 5-502; this includes benign and malign tumors.
- •patients with pre-surgical thin-layer CT or MRT of the liver not older than 6 weeks or patients where a pre-surgical thin-layer CT or MRT of the liver is planned before surgery.
- •written informed consent
排除标准
- •at screening:
- •anamnestic known hypersensitivity against one of the study drugs, their ingredients or drugs with chemically similar structure (in particular paracetamol)
- •participation in another clinical trials within 4 weeks before inclusion
- •patients with previous liver surgery (OPS-Code 5-502), including biliodigestive anastomosis, excluding cholecystectomy.
- •patients which underwent interventions such as radiofrequency ablation, biopsies or smaller surgeries within 6 weeks before inclusion
- •patients anticipated for biliodigestive anastomosis and/or suffering from a Klatskin-tumor
- •patients with a ASA (American Society of Anesthesiologists) classification >3
- •patients anticipated for laparoscopic partial liver resection
- •patients which are intended to be simultaneously treated with an interventional technique (e.g. radio frequency ablation RFA, embolization)
- •patients which are intended to simultaneously get a surgery on other organs (excluding cholecystectomy)
- •patients which are intended to simultaneously get a vascular anastomosis (e.g. portal vein resection)
- •patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)
- •patients with congenital metabolic diseases, in particular hepatic storage diseases
- •hepatic infection with Echinococcus multilocularis
- •patients with known non-infectious, auto-immune conditioned chronic inflammatory diseases (e.g. autoimmune hepatitis, Morbus Crohn, colitis ulcerativa)
- •patients with severe cardiovascular diseases and/or severe diseases of the respiratory system which receive intensive care in any case (e.g. heart surgery, bypass surgery, cardiac valve replacement, unstable angina pectoris, severe coronary heart disease with intervention during the last 6 months, severe COPD (chronic obstructive pulmonary disease), severe asthma with concomitant cortisone medication)
- •patients with severe bacterial infection at screening
- •patients with known immunodeficiency
- •heavy smokers (>20 cigarettes a day)
- •patients which are unable to understand the study and its possible implications because of addiction or other diseases
- •patients who are suspected not to cooperate or to comply to the trial protocol
- •patients accommodated in an institution due to public or legal authority
- •pregnant or lactating women
- •women with child-bearing potential, excluding: negative pregnancy test and commitment to be sexually inactive until day 30 after surgery or discharge; postmenopause (12 months of natural occurring amenorrhoea); at least 6 weeks after ovariectomy with or without hysterectomy
- •at visit 2:
- •patients anticipated for laparoscopic partial liver resection
- •patients which are intended to be simultaneously treated with an interventional technique (e.g. radio frequency ablation RFA, embolization)
- •patients which are intended to simultaneously get a surgery on other organs (excluding cholecystectomy)
- •patients which are intended to simultaneously get a vascular anastomosis (e.g. portal vein resection)
- •patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)
- •hepatic infection with Echinococcus multilocularis
- •patients with severe cardiovascular diseases and/or severe diseases of the respiratory system which receive intensive care in any case (e.g. heart surgery, bypass surgery, cardiac valve replacement, unstable angina pectoris, severe coronary heart disease with intervention during the last 6 months, severe COPD (chronic obstructive pulmonary disease), severe asthma with concomitant cortisone medication)
- •patients anticipated for biliodigestive anastomosis and/or suffering from a Klatskin-tumor
- •patients with a ASA (American Society of Anesthesiologists) classification >3
研究组 & 干预措施
LiMAx-group
Experimental
Intravenous pre- and post-surgical injection of 0.4% 13-C-Methacetin solution. Dosage is adapted due to body weight (2 mg/kg). A LiMAx-test of >150 µg/kg/h would correspond to a general ward indication.
干预措施: 13-C-Methacetin (Drug)
结局指标
主要结局
number of correctly determined positive patients in each trial group
时间窗: no later than day 30 after surgery
Correctly determined positive patients are patients which are transferred to general ward after surgery because of the result of the LiMAx-test (LiMAx-group) or general diagnosis (control group). Patients have to stay at general ward until discharge no later than day 30 after surgery.
次要结局
- specificity(1 year after trial start (anticipated December 2013))
- positive predictive value (PPV)(1 year after trial start (anticipated December 2013))
- number of incorrectly determined positive patients in each trial group(no later than day 30 after surgery)
- sensitivity(1 year after trial start (anticipated December 2013))
- negative predictive value (NPV)(1 year after trial start (anticipated December 2013))
- changes of routine laboratory data(until day 30 after surgery)
- mortality(1 year after trial start (anticipated December 2013))
- total number of complications(1 year after trial start (anticipated December 2013))
- number of patients with post-surgical liver failure (PHLF)(1 year after trial start (anticipated December 2013))
研究者
研究点 (4)
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