Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry. (GESICA)

Catalan Institute of Health

Status: Enrolling

Conditions: Training; Endoscopic Surgical Procedure; Safety

Treatments: Device: Gastroenterostomy

Study type: Observational

Funder types: Other

Identifiers

NCT05128604

GESICA

Details and patient eligibility

About

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].

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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