RecruitingNCT05128604

Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

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


Sponsor

Hospital Universitari de Bellvitge

Enrollment

50 participants

Start Date

May 23, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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 Criteria4

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEGastroenterostomy

Endoscopic ultrasound guided gastroenterostomy


Locations(6)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05128604


Related Trials