Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Recurrent rate of CBDS within two years after ERCP
研究概览
简要总结
The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up to 60% of patients had stone recurrence within two years after stone retrieval by ERCP. Although EPLBD is useful for for extraction of large CBDS with less operation time and mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term recurrence of CBD stones in patients with previous ES. It is a retrospective study with a small sample size (n=94).
Here a prospective, randomized controlled study including two tertiary centers was designed. The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in patients with recurrent CBDS.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent CBDS after ERCP
排除标准
- •Benign or malignant CBD stricture
- •Recurrent stone within 3 months after ERCP
- •Previous endoscopic papillary large balloon dilation (EPLBD)
- •Prior surgery of Bismuth II and Roux-en-Y
- •Septic shock
- •Coagulopathy (INR>1.3), platelet<50000 or using anti-coagulation drugs
- •With expected life span less than 24 months
- •Pregnant women
- •Refusal or unable to give written informed consent
研究组 & 干预措施
control group
The papilla orifice could be enlarged by asphincterotomeif necessary. The stones were retrieved by a basket or a retrieval balloon
EPLBD group
a CRE balloon (diameter 10, 11, 12, 13.5, 15 mm; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast. When the waist disappeared, the balloon was kept inflated for 120s. The stones were then retrieved by a basket or a retrieval balloon.Mechanical lithotripsy was used if necessary
干预措施: endoscopic papillary large balloon dilation (Procedure)
结局指标
主要结局
Recurrent rate of CBDS within two years after ERCP
时间窗: up to 2 years
Within the two years after ERCP, CBDS was found again by CT, MRCP, ERCP or biliary surgery
次要结局
- success rate of stone extraction(up to 2 years)
- recurrent time(up to 2 years)
- performance time of ERCP(up to 2 years)
- success rate of stone extraction in the initial attempt(up to 2 years)
- rate of mechanical lithotripsy(up to 2 years)
- post-ERCP complication(up to 2 years)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China