Gastric Outlet ObstructionPENGUINNCT04660695
Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction
An observational study of Gastric Outlet Obstruction and Gastric Cancer, run by Hospital del Rio Hortega at 5 sites in 2 countries.
Trial summary
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction, Gastric Cancer, Pancreatic Cancer
- What is being tested?
- EUS-guided gastroenterostomy
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Aug 2019to 12 May 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients over 18 years of age submitted to any of the participanting center's endoscopy units to receive a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction or unable to understand the questionnaires will be excluded.
Who may be able to join
- Patients over 18 years of age
- unresectable malignant gastric outlet obstruction
- Undergoing placement of nasobiliary drain assisted EUS-GE
Who cannot join
- Previous gastroduodenal surgery
- Previous endoscopic or surgical treatment for gastric outlet obstruction
- Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment
- Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure
- Unable to understand the questionnaires
- Distal bowel obstruction
Show all 9Show fewer
- Ascites grade 2 or superior
- Uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3).
- Active, symptomatic SARS-CoV-2 infection
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain4 sites
Hospital General Universitario de Alicante
Alicante, 03010
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Río Hortega
Valladolid, 47014
About this study
Official title: Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE).
EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are:
- To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE
- To describe the adverse events encountered
- To describe the proportion of clinical and technical success
- To assess its impact on the patients' quality of life.
- To assess the evolution of the oral intake during the first month after the procedure
Read the detailed description
DESIGN
Prospective multicenter case series
AIMS
Primary aim To describe the proportions of technical and clinical success. To describe different variants in the nasobiliary drain assissted EUS-GE technique, offering a detailed step by step description of the procedure performance by different endoscopists
Secondary aims:
To describe the adverse encountered, their severity according to ASGE standards and their management.
To describe the time elapsed between the procedure and the initial oral intake.
To describe the evolution of the oral intake during the first month after the procedure To assess the impact of the operators experience on procedure times, adverse events and technical issues.
To assess the impact of the procedure on the quality of life of the participating patients.
STUDY POPULATION
All consecutive patients over 18 years of age receiving a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction requiring endoscopic treatment, a distal bowel obstruction, ascites grade 2 or superior, uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3). or unable to understand the questionnaires will be excluded.
INTERVENTION
At inclusion
Informed consent will be obtained. A clinical interview and a physical examination will be performed. TheEuropean Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales will be assessed in a telephone interview.
Endoscopic procedure
All procedures will be performed under sedation. An assistant endoscopist or research nurse will retrieve all data regarding the procedure. Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
Post procedure: Oral liquid intake can be restarted 4h after the procedure in patients presenting no signs or symptoms suggesting any adverse event. Pacients with an adequate tolerance might be discharged.
Follow-up
Clinical telephone interviews by an experienced research nurse will be held via telephone calls 1 day, 7 days and 30 days after the procedure. Oral intake and adverse events will be assessed every visit. Thirty days after the procedure a second evaluation of the EORTC-QLQ-C30 will be performed.
STATISTICAL ANALYSIS
Categorical variables were reported as percentages. Normally distributed continuous variables were reported as the mean with the standard deviation values. Non-normally distributed continuous variables were reported as the median and interquartile range. The EORTC QLQ-C30 descriptive analysis was performed with a specifically programmed Stata command (10). Variables regarding the procedure step by step analysis will only undergo a descriptive analysis. Differences between the different outcomes of the EORTC-QLQ-C30 will be assessed using linear mixed models with fixed effects for baseline values, and interaction with oncological treatment. The statistical analysis will be performed using the Stata package (StataCorp. 2013, College Station, Texas).
- Being tested
- EUS-guided gastroenterostomy
- Medical subject headings
- Gastric Outlet Obstruction, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided gastroenterostomyDevice
Also called AXIOS™ Stent and Electrocautery Enhanced Delivery System (Boston Scientific, Mass)
Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients included will undergo an EUS-guided gastroenterostomy with a 15x10mm or a 20x10mm lumen apposing metal Stent (Axios, Boston Scientific, Mass). Receives: Device: EUS-guided gastroenterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
An adequate stent placement across the GI walls, with one flange in the gastric cavity and the other in the small bowel lumen. It has to be confirmed either fluoroscopically or endoscopically.
Measured: Day +1
Early Clinical Success
Defined as a GOOSS >=2.
Measured: Day +7
Clinical Success
Defined as a GOOSS >=2.
Measured: Day +30
Secondary outcomes (13)
Baseline Gastric outlet obstruction score system (GOOSS)
The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet)
Measured: Baseline
Early Gastric outlet obstruction score system (GOOSS)
The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet)
Measured: day +7
Final Gastric outlet obstruction score system (GOOSS)
The GOOSS is a previously defined classification of Gastric outlet obstruction which incudes 4 categories (0-Nil Per Os; 1 liquids only; 2 soft diet; 3 low residue or full diet)
Measured: day +30
Baseline European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a validated questionnaire (with validated translations in Spanish), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales
Measured: Baseline
Final European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a validated questionnaire (with validated translations in Spanish), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales
Measured: Baseline, day+30
Number of Participants With intraprocedure Treatment-Related Adverse Events as Assessed by the ASGE classification
The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events.
Measured: day+1,
Number of Participants With Early Treatment-Related Adverse Events as Assessed by the ASGE classification
The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events.
Measured: day+7
Number of Participants With Delayed Treatment-Related Adverse Events as Assessed by the ASGE classification
The ASGE classification is a tool developed to describe and assess the severity of endoscopy related adverse events.
Measured: day+30
Recurrent GOO
In patients achieving clinical success in day +7, recurrent GOO is defined as the development of nausea and vomiting and/or a GOOSS<2.
Measured: Day +30
Target bowel loop diameter (mm)
Diameter measured with the EUS of the dilated bowel loop. It should be measured just before placing the stent
Measured: Procedure
Total volume infused (ml)
Volume of saline, methilene blue solution or radiopaque contrast solution instiled to dilate the target bowel loop
Measured: Procedure
Number of patients undergoing balloon dilation
After deploying the stent, it might be dilated with a controlled radial expansion balloon dilator
Measured: Procedure
Type of fluid employed
Three different fluids can be used to dilate the target bowel loop, saline, methilene blue diluted in saline or radiopaque contrast diluted in saline
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Aug 2019
- Primary completion12 May 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Outlet ObstructionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Alicante, Clinica Universidad de Navarra, Universidad de Navarra, Complejo Hospitalario de Navarra, Christian Medical College, Vellore, India
- Responsible party
- Principal investigator, Francisco Javier Garcia Alonso, Hospital del Rio Hortega
- Investigators
- Carlos de la Serna Higuera, MD, Principal investigator, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660695
- Sponsor's protocol ID
- PI152-19
- Acronym
- PENGUIN
- Status last verified
- May 2021
- First submitted
- 23 Nov 2020
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: After the study is completed a csv including all study data can be submitted to a repository or made available to applying investigators.
Publications
Chavarria C, Martin-Alvarez V, Aparicio JR, Subtil JC, Garcia-Alonso FJ, Vila JJ, Martinez-Moreno B, Busto Bea V, de la Serna-Higuera C, Perez-Miranda M. EUS-guided gastroenterostomy using a parallel enteric tube for luminal distension: Prospective multicenter procedural standardization (with video). Endosc Ultrasound. 2025 May-Jun;14(3):129-136. doi: 10.1097/eus.0000000000000123. Epub 2025 Jun 13.
PubMed 41584027Garcia-Alonso FJ, Chavarria C, Subtil JC, Aparicio JR, Busto Bea V, Martinez-Moreno B, Vila JJ, Martin-Alvarez V, Sanchez-Delgado L, de la Serna-Higuera C, Perez-Miranda M. Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction. Gastrointest Endosc. 2023 Jul;98(1):28-35. doi: 10.1016/j.gie.2023.02.015. Epub 2023 Feb 18.
PubMed 36801458
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar
- ClinicalTrials.gov ID
- NCT04660695
- Acronym / sponsor ID
- PENGUIN / PI152-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Alicante, Clinica Universidad de Navarra, Universidad de Navarra, Complejo Hospitalario de Navarra, Christian Medical College, Vellore, India
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 9 Dec 2020 (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.
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE).
EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are:
- To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE
- To describe the adverse events encountered
- To describe the proportion of clinical and technical success
- To assess its impact on the patients' quality of life.
- To assess the evolution of the oral intake during the first month after the procedure
Detailed description
DESIGN
Prospective multicenter case series
AIMS
Primary aim To describe the proportions of technical and clinical success. To describe different variants in the nasobiliary drain assissted EUS-GE technique, offering a detailed step by step description of the procedure performance by different endoscopists
Secondary aims:
To describe the adverse encountered, their severity according to ASGE standards and their management.
To describe the time elapsed between the procedure and the initial oral intake.
To describe the evolution of the oral intake during the first month after the procedure To assess the impact of the operators experience on procedure times, adverse events and technical issues.
To assess the impact of the procedure on the quality of life of the participating patients.
STUDY POPULATION
All consecutive patients over 18 years of age receiving a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction requiring endoscopic treatment, a distal bowel obstruction, ascites grade 2 or superior, uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3). or unable to understand the questionnaires will be excluded.
INTERVENTION
At inclusion
Informed consent will be obtained. A clinical interview and a physical examination will be performed. TheEuropean Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales will be assessed in a telephone interview.
Endoscopic procedure
All procedures will be performed under sedation. An assistant endoscopist or research nurse will retrieve all data regarding the procedure. Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
Post procedure: Oral liquid intake can be restarted 4h after the procedure in patients presenting no signs or symptoms suggesting any adverse event. Pacients with an adequate tolerance might be discharged.
Follow-up
Clinical telephone interviews by an experienced research nurse will be held via telephone calls 1 day, 7 days and 30 days after the procedure. Oral intake and adverse events will be assessed every visit. Thirty days after the procedure a second evaluation of the EORTC-QLQ-C30 will be performed.
STATISTICAL ANALYSIS
Categorical variables were reported as percentages. Normally distributed continuous variables were reported as the mean with the standard deviation values. Non-normally distributed continuous variables were reported as the median and interquartile range. The EORTC QLQ-C30 descriptive analysis was performed with a specifically programmed Stata command (10). Variables regarding the procedure step by step analysis will only undergo a descriptive analysis. Differences between the different outcomes of the EORTC-QLQ-C30 will be assessed using linear mixed models with fixed effects for baseline values, and interaction with oncological treatment. The statistical analysis will be performed using the Stata package (StataCorp. 2013, College Station, Texas).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: EUS-guided gastroenterostomyPatients included will undergo an EUS-guided gastroenterostomy with a 15x10mm or a 20x10mm lumen apposing metal Stent (Axios, Boston Scientific, Mass). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients over 18 years of age submitted to any of the participanting center's endoscopy units to receive a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction or unable to understand the questionnaires will be excluded.
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- unresectable malignant gastric outlet obstruction
- Undergoing placement of nasobiliary drain assisted EUS-GE
Key exclusion criteria (9 listed)
- Previous gastroduodenal surgery
- Previous endoscopic or surgical treatment for gastric outlet obstruction
- Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment
- Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure
- Unable to understand the questionnaires
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 |
|---|---|---|
| EUS-guided gastroenterostomyAlso: AXIOS™ Stent and Electrocautery Enhanced Delivery System (Boston Scientific, Mass)Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device. | Device | Group 1 |
Primary outcome
Technical Success
Time frame: Day +1
An adequate stent placement across the GI walls, with one flange in the gastric cavity and the other in the small bowel lumen. It has to be confirmed either fluoroscopically or endoscopically.
Early Clinical Success
Time frame: Day +7
Defined as a GOOSS >=2.
Clinical Success
Time frame: Day +30
Defined as a GOOSS >=2.
13 secondary outcomes
Baseline Gastric outlet obstruction score system (GOOSS)
Time frame: Baseline
Early Gastric outlet obstruction score system (GOOSS)
Time frame: day +7
Final Gastric outlet obstruction score system (GOOSS)
Time frame: day +30
Baseline European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)
Time frame: Baseline
Final European Organisation for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30)
Time frame: Baseline, day+30
Number of Participants With intraprocedure Treatment-Related Adverse Events as Assessed by the ASGE classification
Time frame: day+1,
Number of Participants With Early Treatment-Related Adverse Events as Assessed by the ASGE classification
Time frame: day+7
Number of Participants With Delayed Treatment-Related Adverse Events as Assessed by the ASGE classification
Time frame: day+30
Recurrent GOO
Time frame: Day +30
Target bowel loop diameter (mm)
Time frame: Procedure
Total volume infused (ml)
Time frame: Procedure
Number of patients undergoing balloon dilation
Time frame: Procedure
Type of fluid employed
Time frame: Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 41584027Chavarria C, Martin-Alvarez V, Aparicio JR, Subtil JC, Garcia-Alonso FJ, Vila JJ, Martinez-Moreno B, Busto Bea V, de la Serna-Higuera C, Perez-Miranda M. EUS-guided gastroenterostomy using a parallel enteric tube for luminal distension: Prospective multicenter procedural standardization (with video). Endosc Ultrasound. 2025 May-Jun;14(3):129-136. doi: 10.1097/eus.0000000000000123. Epub 2025 Jun 13.
- Derived from this study: PubMed 36801458Garcia-Alonso FJ, Chavarria C, Subtil JC, Aparicio JR, Busto Bea V, Martinez-Moreno B, Vila JJ, Martin-Alvarez V, Sanchez-Delgado L, de la Serna-Higuera C, Perez-Miranda M. Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction. Gastrointest Endosc. 2023 Jul;98(1):28-35. doi: 10.1016/j.gie.2023.02.015. Epub 2023 Feb 18.
- Individual participant dataSharing planned: Undecided. After the study is completed a csv including all study data can be submitted to a repository or made available to applying investigators.
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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. This study is not recruiting at the moment.
Carlos de la Serna Higuera, MD principal investigator
Hospital del Rio Hortega
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Outlet Obstruction and Gastric Cancer, run by Hospital del Rio Hortega at 5 sites in 2 countries.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Day +1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660695, which also lists 2 linked publications.
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 14 May 2021.