Actively Recruiting

All Genders
ID05128604

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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

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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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