Clinical trial NCT05128604: Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
Official title: Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopic Surgical Procedure
Safety
Training
Keywords: endoscopic ultrasound
gastroenterostomy
lumen apposing stent
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital del Mar
name: Germans Trias i Pujol Hospital
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Hospital de Granollers
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Virgen Macarena
name: Hospital Universitario La Paz
name: Hospital Universitario del Sureste
First posted: 2021-11-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.

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 \[insert effects\].


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

Primary outcomes:
measure: Safety introduction of EUS-gastroenterostomy
timeFrame: 12 months
Secondary outcomes:
measure: Learning curve
timeFrame: 12 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (Can Ruti)
state: Barcelona, Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona, Catalonia
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona, Catalonia
city: Barcelona
country: Spain
facility: Hospital Del Mar
state: Catalonia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hospital Universitari de Bellvitge - IDIBELL
name: Joan B Gornals, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: