Training for a new endoscopic procedure to treat gastric outlet obstruction
Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
This study is testing a new training program for doctors to safely perform a procedure that helps people with gastric outlet obstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 6 sites (Badalona, Barcelona, Catalonia and 5 other locations) |
| Trial ID | NCT05128604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with gastric outlet obstruction due to either malignant or non-malignant conditions.
Not a fit: Patients with complete stenosis or severe coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of treating gastric outlet obstruction through a minimally invasive procedure.
How similar studies have performed: While this approach is novel in the context of a nationwide registry, similar techniques have shown promise in localized studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Badalona, Barcelona, Catalonia and 5 other locations
- 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 - IDIBELL
- Study coordinator: Joan Gornals, MD, PhD
- Email: jbgornals@bellvitgehospital.cat
- Phone: +34932607682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.