Actively Recruiting
Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry
Led by Hospital Universitari de Bellvitge · Updated on 2025-07-29
50
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari de Bellvitge
Lead Sponsor
H
Hospital Mutua de Terrassa
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research project aims to support the introduction of the gastroenterostomy technique guided by endoscopic ultrasound (EUS-GE) in centers within Catalonia. The study focuses on safely implementing this procedure and providing training for doctors, with the goal of minimizing technical failures and offering help with rescue techniques if needed. It is an observational study assessing the impact of a teaching and live-support model on safety and the learning curve for this endoscopic surgical procedure. The intervention under evaluation is the endoscopic ultrasound-guided gastroenterostomy, which is a device-based surgical procedure. The study includes a teaching protocol and collects information through a prospective registry to observe how well the technique is introduced in practice. This process aims to facilitate safe use and monitor the progress of training over a 12-month period. Participants will be involved in follow-up evaluations during the study to track the safety of the EUS-gastroenterostomy procedure and the learning progress of the medical teams implementing it. Researchers will monitor safety outcomes and learning curves over 12 months. Participants must comply with follow-up tests and assessments related to the procedure. The total observation period for the primary and secondary outcomes is 12 months, ensuring detailed monitoring of the introduction process.
CONDITIONS
Brief Title
Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or more
- Gastric outlet obstruction caused by passable or unpassable stenosis in the antrum-duodenal region from malignant or non-malignant causes
- Ability to understand and sign informed consent form
- Ability to understand the study and comply with follow-up tests during the study duration
You will not qualify if you...
- Presence of massive ascites
- Complete stenosis
- Failure to sign informed consent form
- Intellectual handicap preventing understanding of the study unless a legal representative consents
- Inability to adhere to follow-up requirements
- Severe coagulation disorder: INR > 1.5 not correctible or platelet count < 50,000/mm3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants undergo an endoscopic ultrasound-guided gastroenterostomy procedure.
Approximately 12 months of follow-up visits
Trial Site Locations
Total: 6 locations
1
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain, 08916
Actively Recruiting
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
Actively Recruiting
3
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain, 08221
Actively Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041
Actively Recruiting
5
Hospital Del Mar
Barcelona, Catalonia, Spain
Actively Recruiting
6
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain, 17007
Actively Recruiting
Research Team
J
Joan Gornals, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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