NCT05128604 Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
| NCT ID | NCT05128604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari de Bellvitge |
| Condition | Endoscopic Surgical Procedure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-05-23 |
| Primary Completion | 2026-03-24 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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