Gastric Outlet Obstruction Due to MalignancyNCT07230665
Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting
An observational study of Gastric Outlet Obstruction Due to Malignancy and EUS Guided Enteroenteric Anastomosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction Due to Malignancy, EUS Guided Enteroenteric Anastomosis, Endoscopy, Digestive System
- What is being tested?
- Endoscopic ultrasound-guided gastroenterostomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2021to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This multicenter prospective study involved 13 academic centers in Taiwan
Who may be able to join
- Consecutive patients aged 18 years or older who underwent ES or EUS-GE for unresectable mGOO were enrolled
Who cannot join
- Prior enteral stent placement
- Multi-level bowel obstruction,
- Linitis plastica of the stomach
- A life expectancy of less than one mont
- Uncorrected coagulopathy
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting: a Prospective Cohort Study
Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO [1,2]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months [3].
Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay [4-6]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable.
Read more
In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group [7]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking.
This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.
- Conditions
- Gastric Outlet Obstruction Due to Malignancy, EUS Guided Enteroenteric Anastomosis, Endoscopy, Digestive System
- Being tested
- Endoscopic ultrasound-guided gastroenterostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided gastroenterostomyProcedure or surgery
This procedure was performed under general anesthesia with endotracheal intubation. After identifying the site and extent of the obstruction similar with ES, a 7Fr nasobiliary drain was advanced over the guidewire into the target jejunum under fluoroscopic guidance. A linear echoendoscope was then advanced into the stomach to visualize the jejunum. The jejunal loop was adequately distended by continuously infusing a mixture of saline, contrast medium, and indigo carmine using a standard water pump. Once the target jejunum was confirmed, an antispasmodic was administered. Using the freehand technique, the gastric and jejunal walls were directly punctured with an electrocautery- enhanced LAMS (Hot AXIOS, 20 mm diameter, 10 mm length; Boston Scientific). The LAMS was deployed under EUS and fluoroscopic guidance-first the distal flange into the jejunum, followed by intrachannel release of the proximal flange within the echoendoscope, and then its advancement outside the working channel.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic enteral stent placement | This procedure was performed under fluoroscopic guidance. Either a duodenoscope or a forward-viewing therapeutic endoscope was used to access the obstruction. A 0.025-or 0.035-inch guidewire was advanced into the jejunum beyond the obstruction using a 20mm extraction balloon catheter. After positioning the catheter across the stricture, contrast was injected to determine the location and length of the stricture. An uncovered, through-the-scope duodenal stent (BONASTENT; Standard Sci Tech, Seoul, Korea or WallFlex; Boston Scientific, Marlborough, Mass, USA) with a diameter of 22 mm and a length of 6 to 16 cm, depending on the stricture length, was then deployed to adequately cover both ends of the obstruction under combined fluoroscopic and endoscopic guidance. Receives: Procedure: Endoscopic ultrasound-guided gastroenterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintervention rate
Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms
Measured: one year
Secondary outcomes (5)
Technical success
Successful stent placement across or bypass the obstruction, confirmed by endoscopy or fluoroscopy
Measured: one year
Clinical success
- ≥ 2 point improvement in the gastric outlet obstruction score (GOOS) after stent insertion;
- GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet).
Measured: one year
Gastric outlet obstruction score (GOOS) changes
- GOOS categorized oral intake into four levels (the minimum and maximum score from 0 to 3): 0 (fasting), 1 (liquid diet), 2 (soft diet), and 3 (normal/low-residue diet).
- Comparison the GOOS change before and after stent placement (GOOS recored while the patients was discharge)
Measured: one year
Adverse events (AEs)
AEs, including stent misdeployement, perforation, and bleeding, were classified and graded according to the Adverse Events in GI Endoscopy (AGREE) classification, with a 30-day cut-off distinguishing early and late events.
Measured: one year
Survival
alive until the last follow-up
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start14 Aug 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Outlet Obstruction Due to MalignancyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230665
- Sponsor's protocol ID
- 202108046RINC
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuo YT, Yang CY, Chen JH, Liao SC, Hsieh CL, Wu CH, Lin MY, Chung CS, Chen KC, Lee MH, Shih HY, Lin JC, Sun CK, Tsai MC, Wang HP; Taiwan EUS-GE Study Group (TEGESG). EUS-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction: Morphological Classification to Prevent Stent Misdeployment. Dig Endosc. 2026 Jul;38(7):e70235. doi: 10.1111/den.70235.
PubMed 42466906
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07230665
- Acronym / sponsor ID
- 202108046RINC
- Conditions
- Gastric Outlet Obstruction Due to Malignancy, EUS Guided Enteroenteric Anastomosis, Endoscopy, Digestive System
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (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 (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO [1,2]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months [3].
Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay [4-6]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable.
In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group [7]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking.
This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic enteral stent placement | – | Procedure: Endoscopic ultrasound-guided gastroenterostomyThis procedure was performed under fluoroscopic guidance. Either a duodenoscope or a forward-viewing therapeutic endoscope was used to access the obstruction. A 0.025-or 0.035-inch guidewire was advanced into the jejunum beyond the obstruction using a 20mm extraction balloon catheter. After positioning the catheter across the stricture, contrast was injected to determine the location and length of the stricture. An uncovered, through-the-scope duodenal stent (BONASTENT; Standard Sci Tech, Seoul, Korea or WallFlex; Boston Scientific, Marlborough, Mass, USA) with a diameter of 22 mm and a length of 6 to 16 cm, depending on the stricture length, was then deployed to adequately cover both ends of the obstruction under combined fluoroscopic and endoscopic guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter prospective study involved 13 academic centers in Taiwan
Key inclusion criteria (1 listed)
- Consecutive patients aged 18 years or older who underwent ES or EUS-GE for unresectable mGOO were enrolled
Key exclusion criteria (7 listed)
- Prior enteral stent placement
- Multi-level bowel obstruction,
- Linitis plastica of the stomach
- A life expectancy of less than one mont
- Uncorrected coagulopathy
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 |
|---|---|---|
| Endoscopic ultrasound-guided gastroenterostomyThis procedure was performed under general anesthesia with endotracheal intubation. After identifying the site and extent of the obstruction similar with ES, a 7Fr nasobiliary drain was advanced over the guidewire into the target jejunum under fluoroscopic guidance. A linear echoendoscope was then advanced into the stomach to visualize the jejunum. The jejunal loop was adequately distended by continuously infusing a mixture of saline, contrast medium, and indigo carmine using a standard water pump. Once the target jejunum was confirmed, an antispasmodic was administered. Using the freehand technique, the gastric and jejunal walls were directly punctured with an electrocautery- enhanced LAMS (Hot AXIOS, 20 mm diameter, 10 mm length; Boston Scientific). The LAMS was deployed under EUS and fluoroscopic guidance-first the distal flange into the jejunum, followed by intrachannel release of the proximal flange within the echoendoscope, and then its advancement outside the working channel. | Procedure or surgery | Endoscopic enteral stent placement |
Primary outcome
Reintervention rate
Time frame: one year
Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms
5 secondary outcomes
Technical success
Time frame: one year
Clinical success
Time frame: one year
Gastric outlet obstruction score (GOOS) changes
Time frame: one year
Adverse events (AEs)
Time frame: one year
Survival
Time frame: one year
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 15 Dec 2025.
- Derived from this study: PubMed 42466906Kuo YT, Yang CY, Chen JH, Liao SC, Hsieh CL, Wu CH, Lin MY, Chung CS, Chen KC, Lee MH, Shih HY, Lin JC, Sun CK, Tsai MC, Wang HP; Taiwan EUS-GE Study Group (TEGESG). EUS-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction: Morphological Classification to Prevent Stent Misdeployment. Dig Endosc. 2026 Jul;38(7):e70235. doi: 10.1111/den.70235.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Outlet Obstruction Due to Malignancy and EUS Guided Enteroenteric Anastomosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
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?
Reintervention rate (time frame: one year). 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 NCT07230665, which also lists 1 linked publication.
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 15 Dec 2025.