Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05128604

Acronym

GESICA

Enrollment

Registered

2021-11-22

Start date

2022-05-23

Completion date

2026-09-24

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Surgical Procedure, Safety, Training

Keywords

endoscopic ultrasound, gastroenterostomy, lumen apposing stent

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 \[insert effects\].

Interventions

DEVICEGastroenterostomy

Endoscopic ultrasound guided gastroenterostomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety introduction of EUS-gastroenterostomy	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

Measure	Time frame	Description
Learning curve	12 months	To assess the number of procedures related to a competence in the EUS-Gastroenterostomy

Countries

Spain

Contacts

Primary ContactJoan Gornals, MD, PhD

jbgornals@bellvitgehospital.cat+34932607682

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026