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临床试验/NCT06215040
NCT06215040招募中不适用

Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Score of quality of life

研究概览

简要总结

This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.

详细描述

There is no conflcts for treatment of symptomatic common bile duct stone. As more imaging examination such as healthy screening, more asymptomatic common bile duct stone patients are found. Current guideline for aymptomatic common bile duct stone is removal using endoscopic retrograde cholangiopancreatography. However, the previous studies that support this guideline included patients who just underwent cholecystectomy and were diagnosed as common bile duct stone. There is no prospective study for identify the treatment effectiveness of common bile duct stone removal in asymptomatic patients who are dignosed in healthy screening. Therefore, we are going to find the effectiveness of common bile duct stone removal by comparing questionnarie before and after removal of common bile duct stone in asymptomatic and incidentally found common bile duct stone patients. In addition, we are going to follow up patients who do not want to undergo common bile duct stone removal and find the rate of cholangitis risk. We also want to identify extact complication rate for endoscopic retrograde pancreatocholangiographic procedures in asymptomatic common bile duct stone.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed as common bile duct stone by image modality examination
  • agreement for this study enrollment

排除标准

  • no definite common bile duct stone by image modality examination
  • symptomatic patients who complain with fever/abdominal pain that compatible with common bile duct stone related symptom
  • previously diagnosed as pancreatobiliary malignancy
  • previously treated by endoscopic or percutaneous treatment for bile duct stones
  • severe cardio or pulmonary disease
  • pregnancy or possibility of pregnancy
  • who do not agree with study enrollment

结局指标

主要结局

Score of quality of life

时间窗: 3 months

Compare the quality of life before and after treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Heo

Assistant Professor

Kyungpook National University Hospital

研究点 (1)

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