Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

Safety Clinical Trial

— GESICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128604
• Other study ID #: GESICA
• Status: Recruiting
• Start date: May 23, 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Joan Gornals, MD, PhD
• Phone: +34932607682
• Email: jbgornals[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Surgical Procedure
• Safety
• Training

Intervention

Device:
• Gastroenterostomy
Endoscopic ultrasound guided gastroenterostomy

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol (Can Ruti)	Badalona	Barcelona, Catalonia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona	Catalonia
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Catalonia
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona, Catalonia
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona, Catalonia

Sponsors (11)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Learning curve	To assess the number of procedures related to a competence in the EUS-Gastroenterostomy	12 months