Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

NCT05128604 | Recruiting DMC FDA Device

• 1 other identifier: GESICA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

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 \[insert effects\].

Conditions

Endoscopic Surgical Procedure; Safety; Training

Keywords

endoscopic ultrasound; gastroenterostomy; lumen apposing stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Learning curve

  12 months

Interventions

Gastroenterostomy DEVICE

Endoscopic ultrasound guided gastroenterostomy

Also known as: Endoscopic ultrasound, Lumen apposing stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Hospital Universitari Germans Trias i Pujol (Can Ruti)

Badalona, Barcelona, Catalonia, 08916, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907, Spain

RECRUITING

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Catalonia, 08221, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Hospital Del Mar

Barcelona, Catalonia, Spain

RECRUITING

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

RECRUITING

MeSH Terms

Interventions

Gastroenterostomy; Endosonography

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Joan B Gornals, MD, PhD

  Hospital Universitari de Bellvitge - IDIBELL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Gornals, MD, PhD

CONTACT

+34932607682; jbgornals@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of Endoscopy Programme

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: November 22, 2021
• Study Start: May 23, 2022
• Primary Completion: March 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

ES (6)