Role of Biodegradable Polydioxanone Biliary Stents for the Percutaneous Treatment of Benign Biliary Strictures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.
详细描述
This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis.
From march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life.
A subgroup analysis of anastomotic biliary strictures will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (BBS: ELLA-CS, Hradec Kralove, Czech Republic), for each stenosis, by percutaneous technique.
- •Written informed consent given
排除标准
- •Patients under 18 years old
- •Patients with post-liver transplant biliary strictures
- •Patients for whom no post-intervention follow-up data are available
- •Patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.
结局指标
主要结局
Adverse Events
时间窗: From stent implantation to completion of follow-up, up to 5 years
Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications.
Stent Primary Patency
时间窗: Time from stent implantation to new intervention due to restenosis or occlusion detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests), assessed up to 60 months
Time until new intervention due to re-stenosis or occlusion (detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests)
次要结局
- Technical Success(Immediate (during procedure))
- Length of Hospital Stay(nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days)
研究者
Eva Criado
Principal Investigator
Corporacion Parc Tauli