Management and Outcome of Borderline Common Bile Duct With Stone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- complete clearance rate of the CBD stones
研究概览
简要总结
Evaluation of the best line of treatment of borderline CBD stones associated with gallbladder stones whether by conservative treatment or endoscopic stone extraction as regard complete clearance rate of the CBD stones followed by laparoscopic cholecystectomy. The secondary outcomes are overall complications related to each approach, technical difficulties and conversion rate during laparoscopic cholecystectomy and cost benefit relationship of each line of treatment.
详细描述
Enrolled patients in the study will be randomized to either conservative treatment or ERCP and stone extraction. The randomization process will be done using closed envelop method and will be withdrawn by a nurse in the outpatient clinic.
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Patients in conservative treatment group will receive medical treatment in the form of antibiotics, analgesics and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
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Improvement: If the stone spontaneously passes to the duodenum and CBD is clear completely from the stones proved by US, the patient will undergo laparoscopic cholecystectomy (LC) within 3 days.
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No improvement: the patient will undergo ERCP and then LC.
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Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •CBD diameter less than 10mm.
- •Single or 2 stones in number.
- •Size of stone 5mm or less.
- •Serum bilirubin level less than 10 mg/dl .
- •SGPT, SGOT less than
- •Associated gallbladder stones
排除标准
- •Previous cholecystectomy.
- •History of acute cholecystitis, pancreatitis, or cholangitis.
- •Previous history of endoscopic sphincterotomy.
- •Unfit patients for cholecystectomy.
- •No gallbladder stones.
- •Patients with altered GIT anatomy.
结局指标
主要结局
complete clearance rate of the CBD stones
时间窗: 30 DAYS
complete clearance rate of the CBD stones
次要结局
- overall complications(30 DAYS)
- conversion rate during laparoscopic cholecystectomy(1 day)
研究者
Ayman El Nakeeb
Gastroenterology surgical center, mansoura university
Mansoura University