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Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

Recruiting
All
Phase N/A

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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].

Eligibility

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 details
    Endoscopic Surgical Procedure
    Safety
    Training

NCT05128604

Hospital Universitari de Bellvitge

3 May 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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