Use of Fully-covered, Self-expandable Metallic Stents for First-line Treatment of Benign Bile Duct Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 11
- 主要终点
- Early Clinical Success
研究概览
简要总结
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
详细描述
Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bismuth Type I benign bile duct stricture
- •Objective signs/symptoms related to the stricture
排除标准
- •Suspected malignant etiology for the stricture
- •Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy
- •Bismuth Type II-IV stricture
- •Proximal common hepatic duct diameter < 6 mm
- •Intact gallbladder, except in cases where a stent can be deployed > 1cm below the cystic duct insertion
- •Age < 18 years, pregnancy, incarceration, inability to provide informed consent
- •Karnofsky score ≤ 40
- •Inability to pass a guidewire proximal to the stricture
- •Stricture > 8cm in length
- •Life expectancy < 1 year
- •Concomitant nonanastomotic biliary strictures or biliary casts
结局指标
主要结局
Early Clinical Success
时间窗: Post-stent removal (up to one year after enrollment)
Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.
次要结局
未报告次要终点
研究者
Gregory A. Cote
Associate Professor of Medicine
Medical University of South Carolina