Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- need for a nasobiliary tube
研究概览
简要总结
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
详细描述
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
High risks were defined as diameter of CBD>1.5cm, number of calculi>2, and lithotripsy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
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
- None
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
- •1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD>1.5cm, or number of calculi>2, or lithotripsy during ercp
排除标准
- •1. Clinical diagnosis of liver or biliary malignant tumor.
- •Clinical diagnosis of duodenal malignant tumor
- •Failure or unexpected termination of ERCP
- •Surgery history of gallbladder or bile duct.
研究组 & 干预措施
IDUS examination during ERCP
CBD stones cases with high recurrence risks apply IDUS during ERCP
干预措施: IDUS examination (Procedure)
Control
CBD stones cases with high recurrence risks don't apply IDUS during ERCP
结局指标
主要结局
need for a nasobiliary tube
时间窗: 2 weeks
it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP
recurrence of bile duct stone or cholangitis
时间窗: 48 weeks
patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis
need for stents
时间窗: 4 weeks
it's a Yes or No categorical variable to describe if stents were deployed during ERCP
次要结局
- Platelet count(12 weeks)
- operation time(intraoperative)
- radiation time(4 weeks)
- hospitalization cost(8 weeks)
- Questionnaire of Symptoms and conditions after ERCP(8 weeks)
- Gamma-glutamyl transferase (GGT) test(12 weeks)
- Liver function test (ALT, AST)(12 weeks)
- albumin(12 weeks)
- White blood cell count(12 weeks)
- Red blood cell count(12 weeks)
- total bilirubin, direct bilirubin(12 weeks)
- An alkaline phosphatase (ALP) test(12 weeks)
- whether have a resection of gallbladder checklist(48 weeks)
- total protein(12 weeks)
研究者
Zhao Hang
Director of Department of Gastroenterology
Shanghai Municipal Hospital of Traditional Chinese Medicine