Training for a new endoscopic procedure to treat gastric outlet obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project aims to support the introduction of the endoscopic ultrasound-guided gastroenterostomy technique in various centers across Catalonia. It focuses on training healthcare professionals to safely perform this procedure while minimizing technical failures. The study will evaluate the safety and learning curve associated with this new technique, providing insights into its effectiveness and the necessary support for practitioners. Participants will be monitored for their ability to understand and comply with the study's requirements throughout its duration.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Joan B Gornals, MD, PhD — Hospital Universitari de Bellvitge
• Study coordinator: Joan Gornals, MD, PhD
• Email: jbgornals@bellvitgehospital.cat
• Phone: +34932607682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.