Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Safety introduction of EUS-gastroenterostomy
研究概览
简要总结
This is project of help and support for the introduction of the GASTROENTEROANASTOMOSIS technique guided by ENDOSCOPIC -ULTRASOUND (EUS-GE) in centers in Catalonia, facilitating a teacher training.
The main objective is facilitate a safe introduction of the technique, limiting technical failures, and if necessary, support in rescue techniques.
The goal of this interventional study is to assess the impact of a teaching and on live-support model in the introduction of the gastroenteroanastomosis technique, evaluating its effects in safety and the learning curve.
regarding the results in safety and learning curve of for the introduction [type of study: observational study or clinical trial] is to [learn about, test, compare etc.] in [describe participant population/health conditions]. The main question[s] it aims to answer are:
- [question 1]
- [question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or more
- •Gastric outlet obstruction (GOO) caused by passable /unpassable stenosis in the antrum-duodenal region, to malignant or non-malignant conditions
- •Patient capable of understanding and signing informed consent form
- •Patient understanding the type of study and complying with the follow-up of complementary tests during the study's duration
排除标准
- •Massive ascites.
- •Complete stenosis
- •Failure to sign informed consent form
- •Patients with intellectual handicap who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative
- •Patients unable to adhere to subsequent follow-up requirements
- •Severe coagulation disorder: INR > 1.5 not correctible with administration of plasma and/or platelets < 50,000/mm3
结局指标
主要结局
Safety introduction of EUS-gastroenterostomy
时间窗: 12 months
To determine the safety of this interventional technique, measuring prospectively the adverse events and incidents after after a learning project for helping to introduce this technique.
次要结局
- Learning curve(12 months)
研究者
Joan B Gornals
Principal Investigator, Director of Endoscopy Programme
Hospital Universitari de Bellvitge