EUCTR2014-003932-38-NL进行中（未招募）1 期
Advanced imaging in laparoscopic HIPEC for peritoneal carcinomatosis of colorectal orgin to improve cytoreduction; a feasibility study - Advanced laparoscopic detection of peritoneal carcinomatosis
VU University medical center (VUmc)0 个研究点目标入组 10 人开始时间: 2016年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Oral and written informed consent
- •Age 18 years and older
- •Elective cytoreductive surgery followed by HIPEC
- •Regular preoperative work-up
- •Laparoscopic approach
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients who are legally or mentally incapable or unable to give informed consent
- •Patients younger than 18 years
- •ASA (American Society of Anaesthesiologists) score higher than 3
- •Exclusion criteria for cytoreductive surgery followed by HIPEC
- •Exclusion criteria for resection of colorectal cancer
- •Patients who have had major open abdominal surgery
- •Hypersensitivity reaction to prior usage of indigo carmine or other dyes
- •Severe high blood pressure, cardiac ischemia and heart insufficiency
- •Iodine allergy
- •Patients with hyperthyroidism or autonomous hyperthyroid adenoma
- •Interaction with any of the following medication: any anticonvulsive medicine, bisulphites, haloperidol, heroin, meperidine, metamizol, methadone, morfine, nitrofurantoine, opiate alkaloids, fenobarbital, fenylbutazon, cyclopropane, probenicid, rifamycin, tetracyclines, sulphonamides, fluoroquinolones and hypericin extracts
- •Hypersensitivity reaction to prior usage of indocyanin green injection
- •Hypersensitivity to 5-ALA or porphyrins
- •Acute or chronic types of porphyria
- •Urgent indication for surgery
- •Chronic kidney failure (eGFR<55)
- •Chronic liver failure
研究者
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