Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospital Universitari de Bellvitge
About this trial
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.
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* \[question 1\] * \[question 2\] 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 \[insert effects\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastroenterostomy
DeviceEndoscopic ultrasound guided gastroenterostomy
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Safety introduction of EUS-gastroenterostomy
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.
Time frame
12 monthsSecondary outcomes
1
Learning curve
To assess the number of procedures related to a competence in the EUS-Gastroenterostomy
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari de Bellvitge
Lead sponsor
Hospital Mutua de Terrassa
Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator
Hospital del Mar
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital Universitari de Girona Dr. Josep Trueta
Collaborator
Hospital de Granollers
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
Hospital Universitario Virgen Macarena
Collaborator
Hospital Universitario La Paz
Collaborator
Hospital Universitario del Sureste
Collaborator
Source ClinicalTrials.gov