ISRCTN82923678已完成不适用
Randomised controlled trial of the effects of fish oil emulsion in total parenteral nutrition upon tumour vascularity in patients with hepatic colorectal metastases
niversity Hospitals of Leicester NHS trust (UK)0 个研究点目标入组 20 人开始时间: 2006年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- •Patients with hepatic colorectal metastases, in whom the disease is assessed as amenable to curative resection will be eligible for the study. The inclusion criteria will be:
- •1. Ages 18-80
- •2. Able to give informed written consent
- •3. Diagnosis of resectable hepatic colorectal metastases on radiological and laparoscopic appearance (this trial is only assessing operative disease)
排除标准
- •Patients will be excluded from this trial if they have:
- •1. Malignant disease that is not thought to be potentially operable after laparoscopy
- •2. Patients already taking fish oil supplements (may interfere with results)
- •3. Patients already enrolled into other trials (e.g. of chemotherapy)
- •4. Hypersensitivity to fish, egg or soy protein or to any of the active substances or constituents in the lipid emulsion
- •5. Hyperlipidaemia
- •6. Severe blood coagulation disorders
- •7. Severe renal insufficiency (creatinine >200)
- •8. Any general contra-indications to infusion therapy ? pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
- •9. Any unstable medical conditions ? uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis
- •Patients meeting the above criteria are excluded as they represent inoperable disease, cases where the results would be invalid (already taking fish oil supplements), contraindications to lipid infusion and unstable medical conditions.
- •Patients will also be excluded if they have any contraindications to MRI scanning:
- •1. Cardiac pacemaker
- •2. Other ferromagnetic metal implants not authorised for use in MRI such as certain types of cerebral aneurysm clips
- •3. Claustrophobia
- •4. Body weight or circumference beyond the MRI scanner?s capacity
研究者
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