Lower Fluorescein Sodium Dose on Confocal Laser Endoscopy Image Quality and Yellow Discoloration of the Skin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
研究概览
简要总结
This study was to test an appropriate dose of fluorescein sodium which can provide high image quality to ensure endoscopy examination and have no yellow dye in the skin by a randomized blinded controlled trial.
详细描述
Fluorescein sodium is one of the commonly used staining agents in confocal laser endoscopy, a device for in vivo real-time histological observation of the gastrointestinal mucosa. The conventional intravenous dosage of fluorescein sodium is in the range of 5ml to 10ml of 10% fluorescein. Image quality can be guaranteed with this range of fluorescein sodium, but yellow discoloration of the skin seriously influences daily life. This study was to test whether a lower dose of fluorescein sodium, which has minimal discoloration of skin, can provide satisfied image quality by a randomized blinded controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only those with normal mucosa and minor gastritis from 18 were included.
- •patients with aged 18 years to 80 years
- •patients with normal mucosa and minor gastritis
- •willing to provide informed consent
排除标准
- •serious coagulopathy dysfunction, severe cardiopulmonary disease, bronchial asthma, liver and kidney dysfunction, allergy to fluorescein, pregnancy women or breast feeding.
- •patients with peptic ulcer, gastric cancer, remnant stomach, acute serious gastritis were also excluded.
- •unwilling to provide informed consent
研究组 & 干预措施
group 1
This group patients were given dosages of fluorescein sodium 0.01ml/kg intravenous administration.
干预措施: fluorescein sodium 0.01ml/kg (Drug)
group 2
This group patients were given dosages of fluorescein sodium 0.02ml/kg intravenous administration.
干预措施: fluorescein sodium 0.02ml/kg (Drug)
group 3
This group patients were given dosages of fluorescein sodium 0.05ml/kg intravenous administration.
干预措施: fluorescein sodium 0.05ml/kg (Drug)
group 4
This group patients were given dosages of fluorescein sodium 0.1ml/kg intravenous administration.
干预措施: fluorescein sodium 0.1ml/kg (Drug)
结局指标
主要结局
Different ratios of high resolution CLE images among four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)
时间窗: six months
次要结局
- Different degrees of skin yellow dye of patients in four different fluorescein sodium dose groups(0.01ml/kg,0.02ml/kg,0.05ml/kg,0.1ml/kg)(six months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University