Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

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].

Recruiting

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Key information

Conditions

Endoscopic Surgical Procedure Safety Training

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastroenterostomy

Device

Endoscopic ultrasound guided gastroenterostomy

Other names: Endoscopic ultrasound, Lumen apposing stent

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

Time frame: 12 months

To assess the number of procedures related to a competence in the EUS-Gastroenterostomy

Study contacts

Contact information is provided by the study sponsor or research team.

Joan Gornals, MD, PhD

CONTACT

[email protected]

+34932607682

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital General Universitario Gregorio Marañon
Hospital Mutua de Terrassa
Hospital Universitari de Girona Dr. Josep Trueta
Hospital Universitario La Paz
Hospital Universitario Virgen Macarena
Hospital Universitario del Sureste
Hospital de Granollers
Hospital del Mar

Registry information

Official study title

Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.

Acronym: GESICA

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Nov 22, 2021
Registry last updated: Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed