ISRCTN64076941已完成不适用
Infusion of intraportal autologus mononuclear bone marrow cells as a liver regeneration enhancer prior to extended hepatectomy. A randomised, open-label multicentre phase II clinical trial
Department of Health and National Health Service [Ministerio De Sanidad and Consejeria De Salud] (Spain)0 个研究点目标入组 60 人开始时间: 2011年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients of both sexes aged between 18 and 70
- •2. Normal analytical parameters, defined by:
- •2.1. Leukocytes higher than 3,000
- •2.2. Neutrophils higher than 1,500
- •2.3. Platelets higher than 100,000
- •2.4. AST/ALT less than 1.5 standard institutional range
- •2.5. Creatinine less than 1.5 mg/dl
- •3. Patients with a hepatic space occupying lesion (SOL) which need an extended hepatic resection (of more than five segments)
- •4. The selection must be careful and basically include 4 types of hepatic lesions which must previously be submitted to a hepatic volumetry:
- •4.1. Metastatic disease susceptible to extended right hepatectomy in segment IV
- •4.2. Metastatic disease susceptible to right hepatectomy with suspected liver disease(neoadjuvant chemotherapy) (when hepatic function is unclear, the indocyanine green test can be used)
- •4.3. Bilobar hepatic metastases with multiple nodules in the right lobe, and more than 3 nodules bigger than 30mm in the left hepatic lobe (LHL): tumourectomy of the LHL + ligature of the right portal branch (or post-operative percutaneous embolisation) with a view to carry out a right hepatectomy 4-6 weeks afterwards (two-stage surgery)
- •4.4. Hepatocarcinoma susceptible to extended right hepatectomy
- •4.5. Benign Hepatic Lesions (Haemangiomas, Hydatid Cysts, or Primary Hepatic Tumours/Hepatoblastoma), which because of their extension put the viability of the remaining hepatic tissue at risk
- •5. The pre-operative assessment of the residual hepatic volume should be, following the hepatectomy >30% (>40% in diseased livers)
- •6. The following definitions/measurements/factors should be included in the evaluation:
- •6.1. Total hepatic volume: residual hepatic volume (RHV) + resectable hepatic volume
- •6.2. Resectable hepatic volume: includes the volume of the tumoral lesions plus the surrounding hepatic parenchyma with compromised vascular structures
- •6.3. Functional hepatic volume: is the difference between the THV and the volume of the lesions
- •6.4. Residual Hepatic Volume: Terminal Hepatic Volume (THV) - Hepatic Volume (HV) to be resected
- •7. Patients who give their informed, written consent in order to participate in the study and offer sufficient guarantees regarding their adhesion to the protocol, to be judged by the investigator in charge of patient services
- •8. Women of childbearing age must obtain negative results from a pregnancy test, following the habitual procedures of each hospital at the beginning of inclusion in the study and commit to using a medically approved contraceptive throughout the whole period of the study
排除标准
- •1. Previous neoplastic history or haematological disease (Myeloproliferative disease, Myelodyplastic syndrome or Leukemia)
- •2. Patients with uncontrolled arterial hypertension (with arterial tension of more than 180/110 on more than one occasion)
- •3. Severe heart failure - New York Heart Association Class IV (NYHA IV)
- •4. Patients with malignant ventricular arrythmias or unstable angina
- •5. Diagnosis of Deep Vein Thrombosis (DVT) within the last 3 months
- •6. An active infection or wet gangrene on the day of bone marrow-mononuclear cells (BM-MNCs) infusion
- •7. Concomitant therapy which includes hyperbaric oxygen, vaso-active substances, agents against angiogenesis, cyclooxygenase-II (COX-II) inhibitors
- •8. Body mass index (BMI) of more than 40 Kg/m2
- •9. Patients diagnosed as alcoholics at the moment of inclusion
- •10. Proliferative retinopathy
- •11. A concomitant illness which reduces life expectancy to less than one year
- •12. Difficulty in treatment
- •13. Heart failure or ejection fraction (EF)< 30%
- •14. Cerebrovascular disease or Myocardial infarction in the last 3 months
- •15. Pregnant women or women of childbearing age who do not have an adequate method of contraception
研究者
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