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临床试验/NCT04145843
NCT04145843已完成不适用

Registry to Evaluate the Outcomes Following Algorithmic Approach in the Endoscopic Treatment of Bile Duct Stones

AdventHealth1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AdventHealth
入组人数
42
试验地点
1
主要终点
Rate of ductal clearance at index endoscopic intervention.

研究概览

简要总结

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

详细描述

Gallstone diseases are common, affecting 20 million patients in the United States with associated costs of over US $6 billion. Common bile duct (CBD) stones in turn occur in 15-20% patients with gallstone disease and require treatment due to risk of infection and pancreatitis. Endoscopic treatment via endoscopic retrograde cholangiopancreatography (ERCP) is the treatment modality of choice in CBD stones. The most simple treatment techniques include biliary sphincterotomy and stone extraction via the use of standard devices such as a stone retrieval balloons or stone retrieval baskets. However, patients with difficult bile duct stones require advanced maneuvers namely mechanical lithotripsy, large balloon sphincteroplasty (LBS) of the major duodenal papilla and single operator cholangioscopy-guided lithotripsy (SOC-LL).

Currently, there are no standardized treatment approaches in the management of CBD stones, especially in the management of difficult CBD stones. Therefore, ERCP in patients with difficult CBD stones can be inefficient and prolonged with use of multiple devices and techniques. In an effort to standardize the management of bile duct stones, we have devised an algorithm for the treatment of bile duct stones using current standard of care methods, taking into account the size of bile duct stones, size of bile duct and availability of endoscopic expertise. The objective of this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones
  • Patients 18 years or over

排除标准

  • Patients not undergoing endoscopic therapy for bile duct stones
  • Patients < 18 years of age

结局指标

主要结局

Rate of ductal clearance at index endoscopic intervention.

时间窗: 6 months

Percent of patients that achieve ductal clearance at the index intervention

次要结局

  • Procedure duration(Index procedure)
  • Technical success(Index procedure)
  • Adverse Events(6 months)
  • Crossover to other therapeutic intervention(6 months)
  • Procedural costs(6 months)
  • Total number of needed interventions(6 months)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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