Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide... | NCT05128604

Studies
Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

NCT05128604

Sponsor

Hospital Universitari de Bellvitge

Status

Recruiting

Last Update Posted

Jul 29, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Endoscopic Surgical Procedure
Safety
Training

Interventions

Gastroenterostomy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2022Actual

Primary Completion Date

Mar 24, 2026Estimated

Completion Date

Sep 24, 2026Estimated

First Submitted Date

Jul 11, 2021

First Submission Date that Met QC Criteria

Nov 9, 2021

First Posted Date

Nov 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2025

Last Update Posted Date

Jul 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joan B Gornals, Principal Investigator, Director of Endoscopy Programme, Hospital Universitari de BellvitgePrincipal Investigator

Lead Sponsor

Hospital Universitari de BellvitgeOTHER

Collaborators

Name	Class
Hospital Mutua de Terrassa	OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	OTHER
Hospital del Mar	OTHER
Germans Trias i Pujol Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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].

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastroenterostomy	Device	Endoscopic ultrasound guided gastroenterostomy		Endoscopic ultrasound Lumen apposing stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety introduction of EUS-gastroenterostomy	To determine the safety of this interventional technique, measuring prospectively the adverse events and incidents after after a learning project for helping to introduce this technique.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Learning curve	To assess the number of procedures related to a competence in the EUS-Gastroenterostomy	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joan Gornals, MD, PhD	Contact	+34932607682		jbgornals@bellvitgehospital.cat

Overall Officials

Name	Affiliation	Role
Joan B Gornals, MD, PhD	Hospital Universitari de Bellvitge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias i Pujol (Can Ruti)	Recruiting	Badalona	Barcelona, Catalonia	08916	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005763	Gastroenterostomy
D019160	Endosonography

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures
D014463	Ultrasonography

Browse Leaves

Not provided

Browse Branches

Not provided