Immediate Versus Elective Endoscopic Removal of Large Common Bile Duct Stones in High-Risk Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rate of complete stone clearance
研究概览
简要总结
The goal of this clinical trial is to compare two different approaches for removing large or multiple stones from the common bile duct in older adults with chronic diseases. The main questions it aims to answer are:
Is it better to remove the stones immediately during the first endoscopic procedure? Or is it safer and more effective to place a temporary plastic stent first and remove the stones later?
Researchers will compare these two approaches to see which one leads to better stone clearance and fewer complications.
Participants will:
Undergo an endoscopic procedure (ERCP) to treat their bile duct stones. Be randomly assigned to either have immediate stone removal or have a stent placed first, with stone removal scheduled 8-12 weeks later.
Attend follow-up visits to monitor their recovery and check for complications.
This study is being conducted at the National Liver Institute, Menoufia University, Egypt.
详细描述
This study was designed to evaluate two different endoscopic treatment strategies for managing large or multiple common bile duct (CBD) stones in elderly patients considered high-risk due to age and comorbid conditions. The research was conducted at the National Liver Institute, Menoufia University in Egypt, a tertiary care center with a high volume of hepatobiliary cases and extensive expertise in endoscopic retrograde cholangiopancreatography (ERCP).
Study Design and Population This was a prospective, randomized, comparative clinical trial conducted between February 2022 and September 2024. A total of 400 patients aged 65 years or older, with a Charlson Comorbidity Index (CCI) ≥ 3 and radiologically confirmed large or multiple CBD stones, were enrolled. Large stones were defined as those with a diameter ≥15 mm; multiple stones were defined as three or more stones, each measuring ≥10 mm. Stone size and number were confirmed by computed tomography (CT) or magnetic resonance cholangiopancreatography (MRCP).
Eligible patients were randomly assigned in a 1:1 ratio to one of two groups:
Group A (Stent-first approach): Underwent initial biliary stenting followed by elective stone extraction 8-12 weeks later.
Group B (Stone retrieval-first approach): Underwent immediate endoscopic stone removal during the index ERCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Charlson Comorbidity Index (CCI) ≥ 3
- •Presence of large or multiple CBD stones (defined as ≥1 stone ≥15 mm or ≥3 stones each ≥10 mm on imaging)
- •Ability to provide informed consent (or via legal representative).
排除标准
- •Contraindications to ERCP or general anesthesia
- •History of biliary surgery or altered anatomy
- •Benign or malignant strictures of the distal CBD
- •Intrahepatic bile duct stones
- •Moderate to severe cholangitis
- •Malignancy or serious condition with life expectancy <6 months
研究组 & 干预措施
Group A (Stent-first Approach)
Group A patients had a temporary plastic stent placed to facilitate bile drainage, with elective stone removal scheduled 8-12 weeks later.
干预措施: The endoscopic retrograde cholangiopancreatography (ERCP) with insertion of a plastic stent. (Procedure)
Group B (Stone Retrieval-first Approach)
In Group B, patients underwent immediate stone extraction attempts using conventional techniques such as basket, balloon, or mechanical lithotripsy as needed.
干预措施: The endoscopic retrograde cholangiopancreatography (ERCP) with immediate stone extraction attempts. (Procedure)
结局指标
主要结局
Rate of complete stone clearance
时间窗: One month
complete removal of all detectable stones from the common bile duct without the need for additional procedures
次要结局
- ERCP-related adverse events(Three months)
研究者
Gasser Ibrahim El-Azab
Professor of Hepatology and Gastroenterology
National Liver Institute, Egypt