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临床试验/NCT02329977
NCT02329977已完成不适用

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Duodenal-biliary reflux rate

研究概览

简要总结

ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

入选标准

  • Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.

排除标准

  • Gallbladder stones or hepatolithiasis;
  • Stenosis of biliary duct;
  • Incomplete common bile duct stone removal by ERCP;
  • Common bile duct stent;
  • Unable to provide informed consent.

结局指标

主要结局

Duodenal-biliary reflux rate

时间窗: up to 6 months

The proportion of patients with barium reflux into bile duct during the standard barium meal examination.

次要结局

  • Distal common bile duct angle(up to 6 months)
  • Maximal CBD diameter(up to 6 months)
  • Peripapillary diverticulum(up to 6 months)
  • Pneumobilia(up to 6 months)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (1)

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