Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

NCT ID: NCT05128604

Last Updated: 2025-07-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-23

Study Completion Date

2026-09-24

Brief Summary

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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 \[insert effects\].

Detailed Description

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Conditions

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Endoscopic Surgical Procedure Safety Training

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Gastroenterostomy

Endoscopic ultrasound guided gastroenterostomy

Intervention Type DEVICE

Other Intervention Names

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Endoscopic ultrasound Lumen apposing stent

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Mutua de Terrassa

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Hospital del Mar

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Hospital Universitari de Girona Dr. Josep Trueta

UNKNOWN

Sponsor Role collaborator

Hospital de Granollers

OTHER

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Hospital Universitario del Sureste

OTHER

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Joan B Gornals

Principal Investigator, Director of Endoscopy Programme

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Del Mar

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Joan Gornals, MD, PhD

Role: CONTACT

+34932607682

Facility Contacts

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Juan A Colán, MD

Role: primary

00 (34) 934 65 12 00

Role: backup

00 (34) 934 65 12 00

Joan B Gornals, MD, PhD

Role: primary

+34 93 260 76 82 ext. 2624

Daniel Luna, MD

Role: backup

+34 93 260 76 82 ext. 2624

Carme Loras, MD, PhD

Role: primary

00 (34) 937 36 50 50

Role: backup

00 (34) 937 36 50 50

Charlie guarner Argente, MD, PhD

Role: primary

00 (34) 932919000

Role: backup

00 (34) 932919000

Luis Barranco, MD

Role: primary

00 (34) 932 48 30 00

Role: backup

00 (34) 932 48 30 00

Carlos Huertas, MD, PhD

Role: primary

00(34) 972 94 02 00

Role: backup

00(34) 972 94 02 00

Other Identifiers

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GESICA

Identifier Type: -

Identifier Source: org_study_id

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