Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- whether the complete enteroscopy is achieved?
研究概览
简要总结
Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding
详细描述
Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work.
Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or known small-bowel bleeding
排除标准
- •coagulation disorders
- •prior surgery of the small bowel and colon
研究组 & 干预措施
Double-balloon enteroscopy
DBE for suspected or known small-bowel bleeding
干预措施: Double-balloon enteroscopy (Procedure)
Single-balloon enteroscopy
SBE for suspected or known small-bowel bleeding
干预措施: Single-balloon enteroscopy (Procedure)
结局指标
主要结局
whether the complete enteroscopy is achieved?
时间窗: 2 hours
the rate of complete enteroscopy in both groups.
次要结局
- Preparation time(2 hours)
- Investigation time(2 hours)
- side effects(2 days)
- Diagnostic yield(2 hours)