Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Time of procedure.
研究概览
简要总结
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
详细描述
Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All cases of difficult common bile duct stones leading to variable occlusion.
- •Patients fit for intervention.
- •Patients informed consent for study.
排除标准
- •Surgically unfit cases according to ASA
- •Locally advanced irresectable cases.
- •Patients refuse consent to participate in the study.
研究组 & 干预措施
One session application of (ERCP) in the management of common bile duct stones.
One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
干预措施: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) (Procedure)
Two sessions application of (ERCP) in the management of common bile duct stones.
Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
干预措施: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) (Procedure)
结局指标
主要结局
Time of procedure.
时间窗: On the day of determined procedure.
This is measured in hours.
Width of CBD.
时间窗: Baseline.
This is measured in millimeters.
Degree of stone clearance and complications.
时间窗: Baseline.
Those are determined by close monitoring of patients whether after ERCP or surgery.
Postoperative morbidity and mortality.
时间窗: Baseline.
Those are measures in percentage of patients in the study.
Rate of stone size reduction.
时间窗: Baseline.
This is measured in millimeters.
次要结局
- Postoperative hospital stay.(Baseline.)
- Postoperative hemorrhage.(Baseline.)
- Blood loss during the procedure.(Baseline.)
- Postoperative wound infection.(Baseline.)
- Postoperative 30 day mortality rate.(Baseline.)
研究者
Zyad Osama Harith
Zyad Osama Harith Abulatif (General surgery resident)
Assiut University
