Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

Recruiting

• Conditions: Endoscopic Surgical Procedure; Safety; Training

• Registration Number: NCT05128604
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

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* \[question 2\] 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 \[insert effects\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Study Start: 2022-05-23
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-12-24
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Learning curve	12 months	To assess the number of procedures related to a competence in the EUS-Gastroenterostomy

Trial Locations

Locations (6)

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Catalonia, Spain

Hospital Universitari Germans Trias i Pujol (Can Ruti); 🇪🇸 Badalona, Barcelona, Catalonia, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Universitari de Girona Doctor Josep Trueta; 🇪🇸 Girona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain