*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
研究概览
简要总结
Primary objective:
Compare recurrence rates of CBD stones in stented versus non-stented patients.
Secondary objectives:
Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.
详细描述
Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (**ERCP**) with stone extraction is the gold standard treatment, achieving >90% success rates in ductal clearance.
Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .
To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"Inclusion Criteria":
- •Age > 18 years.
- •Documented CBD stones by various imaging or ERCP.
- •Successful biliary clearance by ERCP.
- •Scheduled for elective cholecystectomy within 3 months.
- •Provide written informed consent.
排除标准
- •Previous biliary surgery.
- •Known malignancy involving the biliary system.
- •Comorbid conditions preventing surgery such as bleeding tendency.
- •Pregnancy.
- •Failure to obtain consent.
- •Failed stone clearance.
研究组 & 干预措施
CASE WITH cbd STONES
Age > 18 years.
Documented CBD stones by various imaging or ERCP.
Successful biliary clearance by ERCP.
Scheduled for elective cholecystectomy within 3 months.
Provide written informed consent.
干预措施: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent (Device)
CASE WITH cbd STONES
Age > 18 years.
Documented CBD stones by various imaging or ERCP.
Successful biliary clearance by ERCP.
Scheduled for elective cholecystectomy within 3 months.
Provide written informed consent.
干预措施: biliary stent (Device)
结局指标
主要结局
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
时间窗: 3 months
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
次要结局
未报告次要终点
研究者
Huda Mokhtar Salim
Assistant lecturer
Assiut University