Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Short Term Success Rate in the Resolution of Biliary Strictures
研究概览
简要总结
The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.
详细描述
In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Subject is 18 years or older
- •Subject has benign biliary stricture
- •Subject must be able to give informed consent
排除标准
- •Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- •The subject is unable to give informed consent
结局指标
主要结局
Short Term Success Rate in the Resolution of Biliary Strictures
时间窗: 6 months
Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.
Long-term Success Rate in Resolution of Biliary Strictures
时间窗: at least 12 months after stent removal
Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.
次要结局
- Ease of Stent Removal(at time of procedure)
- Frequency and Severity of Adverse Events (Including Stent Migration)(up to 12 months)
- Number of Endoscopic Treatments Per Patient(At time of procedure)