Prospective Registry Of Therapeutic EndoscopiC ulTrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates.
The study also includes standard alternatives to T-EUS procedures for outcomes comparison.
详细描述
This is an observational, prospective, single centre study. This registry aims to evaluate long-term clinical success of EUS-guided therapeutic interventions (T-EUS), as well as adverse events, and clinical and technical variables asociated with clinical success and adverse events.
For the purpose of this registry, the following procedures will be considered to be T-EUS procedures:
- EUS-guided collection drainage
- EUS-guided biliary drainage
- EUS-guided gallbladder drainage
- EUS-guided gastro-enterostomy
- EUS-directed ERCP
- EUS-guided pancreatic duct drainage
Each patient will be assigned to a procedure following standard clinical practice, in most instances following a routinely multidisciplinary discussion.
Patients eligible for the abovementioned clinical indications, but undergoing alternative procedures (e.g. other endoscopic procedures, surgical interventions or percutaneous interventions) will be enrolled in the registry as "controls" according to specific research questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •subjects candidate to therapeutic EUS (T-EUS) procedures for any underlying disease
- •subject eligible to T-EUS procedures but undergoing other non-EUS based endoscopic procedures, percutaneous or surgical procedures
- •18 years old or older
- •able to provide an informed consent to inclusion.
排除标准
- •age < 18 years
- •inability or unwillingness to sign the informed consent form (ICF)
- •contra-indication for endoscopy or use of fluoroscopy
研究组 & 干预措施
Therapeutic EUS
Procedures involving Linear Echoendoscopes to create a communication between the gastrointestinal tract and a target organ (biliary tree, pancreatic duct, fluid collection, gallbladder, downstream gastrointestinal tract) through plastic or metal stents.
干预措施: Therapeutic EUS (Procedure)
Controls
Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage)
干预措施: Percutaneous Procedures (Procedure)
Controls
Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage)
干预措施: Surgical Interventions (Procedure)
Controls
Patients eligible for T-EUS procedures, but undergoing non-EUS based endoscopic procedures (e.g. ERCP or enteral stenting), surgical interventions or percutaneous interventions (e.g. Percutaneous Biliary Drainage)
干预措施: non-EUS-based endoscopic procedures (Procedure)
结局指标
主要结局
Clinical Success
时间窗: 30 days
* EUS-guided collection drainage: Resolution or reduction of \> 50% of fluid collections * EUS-guided biliary drainage \[valid also for ERCP with stenting\]: Reduction of \>50% of bilirubin OR management of choledocholithiasis OR resolution of cholangitis * EUS-guided gallbladder drainage: Improvement of clinical symptoms or relief of inflammatory signs/symptoms related to cholecystitis * EUS-guided gastro-jejunostomy \[valid also for enteral stenting\]: Resumption of oral intake (Gastric Outlet Obstruction Scoring System \>/= 2 id est at least semisolid food) * EUS-directed ERCP: Possibility to perform ERCP * EUS-guided pancreatic duct drainage: Relief of abdominal pain and reduction of analgesic drug requirement during follow-up OR reduction in the rate of recurrent pancreatitis.
次要结局
- Adverse events(12 months)
研究者
Paolo Giorgio Arcidiacono, MD
Prof. Dr.
IRCCS San Raffaele