A Comparison of Endoscopic Ultrasound Insertion Methods: Conventional vs Inflated Balloon Method
试验速览
- 阶段
- 不适用
- 入组人数
- 482
- 主要终点
- Throat pain
研究概览
简要总结
Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon inflation while EUS insertion could result in decreased throat damage and pain, there is no data to back up. We designed a single center randomized pilot study to compare throat pain caused by EUS insertion with conventional vs balloon inflation method.
详细描述
All patients who are undergoing EUS with radial type echoendoscope will be asked for an informed consent. Subjects will be randomized to conventional insertion arm and balloon inflated insertion arm. All patients will be sedated according to SNUH endoscopy center protocol. Conventional insertion will be done in conventional insertion group, and balloon inflation before the start of procedure will be done in balloon inflated insertion arm. After the EUS procedure is finished, subject will be moved to a recovery room. As soon as the subject is recovered from sedation, throat pain will be assessed in NRS scale and be recoreded. Information of insertion failure and balloon damage during insertion will be also collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 20 to 80
- •Patients undergoing EUS with radial echoendoscope
排除标准
- •Refuse to participate the study
- •Refuse EUS procedure
结局指标
主要结局
Throat pain
时间窗: Assess right after the end of the EUS procedure
Throat pain assessed by NRS scale 5 or over will be considered as positive
次要结局
- Throat pain intensity(Assess right after the end of the EUS procedure)
- EUS Insertion failure rate(Right after insertion)
- Damaged balloon rate(during EUS procedure)