Endoscopic Surgical ProcedureGESICANCT05128604
Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.
An observational study of Endoscopic Surgical Procedure and Safety, run by Hospital Universitari de Bellvitge at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endoscopic Surgical Procedure, Safety, Training
- What is being tested?
- Gastroenterostomy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesSpain
- Study dates
- 23 May 2022to 24 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, 08916
Juan A Colán, MD, 00 (34) 934 65 12 00, jacolanh.germanstrias@gencat.cat
00 (34) 934 65 12 00
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Charlie guarner Argente, MD, PhD, 00 (34) 932919000, CGuarnerA@santpau.cat
00 (34) 932919000
- Recruiting
Hospital Del Mar
Barcelona, Catalonia
Luis Barranco, MD, 00 (34) 932 48 30 00, luisbarranco@gmail.com
00 (34) 932 48 30 00
- Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, 17007
Carlos Huertas, MD, PhD, 00(34) 972 94 02 00, chuertas.girona.ics@gencat.cat
00(34) 972 94 02 00
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907
Joan B Gornals, MD, PhD, +34 93 260 76 82 ext. 2624, jgornals@bellvitgehospital.cat
Daniel Luna, MD, +34 93 260 76 82 ext. 2624, danii.luna23@gmail.com
- Recruiting
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, 08221
Carme Loras, MD, PhD, 00 (34) 937 36 50 50, clorasalas@gmail.com
00 (34) 937 36 50 50
About this study
Official title: Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
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.
Read more
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].
- Conditions
- Endoscopic Surgical Procedure, Safety, Training
- Being tested
- Gastroenterostomy
- Keywords
- endoscopic ultrasound, gastroenterostomy, lumen apposing stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroenterostomyDevice
Also called Endoscopic ultrasound, Lumen apposing stent
Endoscopic ultrasound guided gastroenterostomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Learning curve
To assess the number of procedures related to a competence in the EUS-Gastroenterostomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start23 May 2022
- Primary completion24 Mar 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar, Germans Trias i Pujol Hospital, Hospital Universitari de Girona Dr. Josep Trueta, Hospital de Granollers, Hospital General Universitario Gregorio Marañon, Hospital Universitario Virgen Macarena, Hospital Universitario La Paz, Hospital Universitario del Sureste
- Responsible party
- Principal investigator, Joan B Gornals, Hospital Universitari de Bellvitge
- Investigators
- Joan B Gornals, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128604
- Sponsor's protocol ID
- GESICA
- Acronym
- GESICA
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2021
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction Of Endoscopic Ultrasound-Guided Gastroenterostomy Based On A Learning Protocol And Prospective Registry.
- ClinicalTrials.gov ID
- NCT05128604
- Acronym / sponsor ID
- GESICA / GESICA
- Conditions
- Endoscopic Surgical Procedure, Safety, Training
- Keywords
- endoscopic ultrasound, gastroenterostomy, lumen apposing stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital del Mar, Germans Trias i Pujol Hospital, Hospital Universitari de Girona Dr. Josep Trueta, Hospital de Granollers, Hospital General Universitario Gregorio Marañon, Hospital Universitario Virgen Macarena, Hospital Universitario La Paz, Hospital Universitario del Sureste
- Study start
- 23 May 2022 (actual)
- Primary completion
- 24 Mar 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sympotmatic Gastric outlet obstruction (GOO) related to malignant or notn-malignant conditions.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastroenterostomyAlso: Endoscopic ultrasound, Lumen apposing stentEndoscopic ultrasound guided gastroenterostomy | Device | – |
Primary outcome
Safety introduction of EUS-gastroenterostomy
Time frame: 12 months
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.
1 secondary outcome
Learning curve
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan B Gornals, MD, PhD principal investigator
Hospital Universitari de Bellvitge
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Surgical Procedure and Safety, run by Hospital Universitari de Bellvitge at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Gornals, MD, PhD (+34932607682, jbgornals@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety introduction of EUS-gastroenterostomy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.