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Recruiting NCT05128604

Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

— Observational Endoscopic Surgical Procedure Safety Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gastroenterostomy.
Who it may be relevant to
Registry conditions: Endoscopic Surgical Procedure, Safety, Training. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 \[insert effects\].

Interventions

  • Device Gastroenterostomy
    Endoscopic ultrasound guided gastroenterostomy

Primary outcome measures

  • Safety introduction of EUS-gastroenterostomy [Time frame: 12 months]
Secondary outcome measures (1)
  • Learning curve [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 6 centers
  • Hospital Universitari Germans Trias i Pujol (Can Ruti) — Badalona
  • Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Universitari Mútua de Terrassa — Terrassa
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Del Mar — Barcelona
  • Hospital Universitari de Girona Doctor Josep Trueta — Girona

Identifiers

NCT: NCT05128604 · GESICA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗