A Prospective Double-blind, Randomized, Sham-controlled Trial to Evaluate the Effect of a Lead Free Drape on Scatter Radiation Exposure to Endoscopy Staff During Endoscopic Retrograde Cholangiopancreatography
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Amount of radiation exposure
研究概览
简要总结
ERCP is associated with radiation exposure to the endoscopist and staff, which may be significant at high volume programs despite the use of lead aprons. We hypothesize that draping of the fluoroscopy image intensifier may significantly reduce staff radiation exposure and help achieve implementation of the ALARA (As Low As Reasonably Achievable) principle.
详细描述
A total of 100 consecutive ERCP procedures were randomly assigned to the radiation-attenuating or sham drape in a 1:1 ratio. There were 2 subjects, the endoscopists performing ERCP and the nurse assisting in the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the ERCP procedures done by the same endoscopist and nurse are enrolled
- •Patients age >19
排除标准
- •Fluoroscopic procedures other than ERCP were excluded.
结局指标
主要结局
Amount of radiation exposure
时间窗: Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes
Comparing the use of a lead-free protective drape containing bismuth and antimony and a sterile sham protective drape, radiation dose (RD) was measured at 3 different sites (endoscopist's eye (1) and thyroid (2), and assisting nurse's thyroid (3)) with personal dosimeters placed outside of eyeglass frames and the thyroid shield. The unit of measurement is each event. The subject was subjected to radiation during 100 Endoscopic retrograde cholangiopancreatography procedures.Both groups used standard of care lead protection.
次要结局
- Estimate cumulative annual radiation risk(Length of Endoscopic retrograde cholangiopancreatography, average 5 minutes)