Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
NCT ID: NCT05128604
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-05-23
2026-09-24
Brief Summary
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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 \[insert effects\].
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Gastroenterostomy
Endoscopic ultrasound guided gastroenterostomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Hospital Mutua de Terrassa
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Hospital del Mar
OTHER
Germans Trias i Pujol Hospital
OTHER
Hospital Universitari de Girona Dr. Josep Trueta
UNKNOWN
Hospital de Granollers
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario Virgen Macarena
OTHER
Hospital Universitario La Paz
OTHER
Hospital Universitario del Sureste
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Joan B Gornals
Principal Investigator, Director of Endoscopy Programme
Principal Investigators
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Joan B Gornals, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge - IDIBELL
Locations
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Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Del Mar
Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Role: backup
Role: backup
Role: backup
Role: backup
Other Identifiers
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GESICA
Identifier Type: -
Identifier Source: org_study_id
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