Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endoscopic Surgical Procedure
- Sponsor
- Hospital Universitari de Bellvitge
- Enrollment
- 50
- Locations
- 6
- Primary Endpoint
- Safety introduction of EUS-gastroenterostomy
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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].
Investigators
Joan B Gornals
Principal Investigator, Director of Endoscopy Programme
Hospital Universitari de Bellvitge
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Safety introduction of EUS-gastroenterostomy
Time Frame: 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.
Secondary Outcomes
- Learning curve(12 months)