Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry. (GESICA)

July 25, 2025 updated by: Joan B Gornals, Hospital Universitari de Bellvitge

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Contact:
          • Phone Number: 00 (34) 932919000
    • Barcelona, Catalonia
      • Badalona, Barcelona, Catalonia, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol (Can Ruti)
        • Contact:
        • Contact:
          • Phone Number: 00 (34) 934 65 12 00
      • L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Claudia F. Consiglieri, MD, PhD
        • Sub-Investigator:
          • Daniel Luna, MD
      • Terrassa, Barcelona, Catalonia, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua de Terrassa
        • Contact:
        • Contact:
          • Phone Number: 00 (34) 937 36 50 50
        • Sub-Investigator:
          • Xavi Andújar, MD
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Recruiting
        • Hospital del Mar
        • Contact:
        • Contact:
          • Phone Number: 00 (34) 932 48 30 00
      • Girona, Catalonia, Spain, 17007
        • Recruiting
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Contact:
        • Contact:
          • Phone Number: 00(34) 972 94 02 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

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

Investigators

  • Principal Investigator: Joan B Gornals, MD, PhD, Hospital Universitari de Bellvitge - IDIBELL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2022

Primary Completion (Estimated)

March 24, 2026

Study Completion (Estimated)

September 24, 2026

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GESICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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