Malignant Gastric Outlet ObstructionNCT06567691
Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy
A study testing EUS Gastrojejunostomy, Surgical Gastrojejunostomy and Gastric Outlet Obstruction Scoring System (GOOSS) in people with Malignant Gastric Outlet Obstruction, run by Vanderbilt University Medical Center.
Trial summary
Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Gastric Outlet Obstruction
- What is being tested?
- EUS Gastrojejunostomy, Surgical Gastrojejunostomy and Gastric Outlet Obstruction Scoring System (GOOSS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Able to provide informed consent
- Biopsy-proven cancer
- Cancer without surgical resection as a curative treatment option
- Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
Who cannot join
- Age <18 years
- Pregnancy
- Unable to provide informed consent
- White Blood Count < 3,000
- Absolute Neutrophil Count < 1,500
- International normalized ratio > 1.6
Show all 15Show fewer
- Platelet count < 100,000
- Cancer with surgical resection as a curative treatment option
- Surgically altered foregut anatomy
- Multifocal intestinal obstruction
- Abdominal ascites prohibitive of surgical candidacy
- Abdominal wall mesh prohibitive of surgical candidacy
- Child's Class B or C cirrhosis
- Gastroesophageal varices or known portal hypertension
- Body mass index >40
About this study
Official title: Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial
Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.
EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach [4]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.
- Conditions
- Malignant Gastric Outlet Obstruction
- Being tested
- EUS Gastrojejunostomy, Surgical Gastrojejunostomy, Gastric Outlet Obstruction Scoring System (GOOSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS GastrojejunostomyProcedure or surgery
Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed.
Surgical GastrojejunostomyProcedure or surgery
Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon.
Gastric Outlet Obstruction Scoring System (GOOSS)Other
A previously validated instrument for assessing tolerance of oral intake.
| Study group | Role | What they receive |
|---|---|---|
| EUS Gastrojejunostomy | Active comparator | Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure Receives: Procedure: EUS Gastrojejunostomy; Other: Gastric Outlet Obstruction Scoring System (GOOSS) |
| Surgical Gastrojejunostomy | Active comparator | Patient will undergo Surgical Gastrojejunostomy procedure. Receives: Procedure: Surgical Gastrojejunostomy; Other: Gastric Outlet Obstruction Scoring System (GOOSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy
A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake.
0: no oral intake
- oral liquids only
- soft solids
- low residue or full diet This will be given to subjects
Measured: 1 day post-operative
Compare post procedure length of hospital stay
This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment.
Measured: 14 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Aug 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: Unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yachimski, Vanderbilt University Medical Center
- Investigators
- Patrick Yachimski, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567691
- Sponsor's protocol ID
- 240747
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06567691
- Acronym / sponsor ID
- 240747
- Conditions
- Malignant Gastric Outlet Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 23 Aug 2024 (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.
Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach.
EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach [4]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS Gastrojejunostomy | Active comparator | Procedure: EUS Gastrojejunostomy, Other: Gastric Outlet Obstruction Scoring System (GOOSS)Patient will undergo an Endoscopic Ultrasound (EUS) Gastrojejunostomy procedure |
| Surgical Gastrojejunostomy | Active comparator | Procedure: Surgical Gastrojejunostomy, Other: Gastric Outlet Obstruction Scoring System (GOOSS)Patient will undergo Surgical Gastrojejunostomy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Able to provide informed consent
- Biopsy-proven cancer
- Cancer without surgical resection as a curative treatment option
- Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum
Key exclusion criteria (15 listed)
- Age <18 years
- Pregnancy
- Unable to provide informed consent
- White Blood Count < 3,000
- Absolute Neutrophil Count < 1,500
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 GastrojejunostomyEndoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriate stent placement will be confirmed. | Procedure or surgery | EUS Gastrojejunostomy |
| Surgical GastrojejunostomyGastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be at the discretion of the operating surgeon and if performed, will be performed via a Stamm technique. Abdominal fascial closure will be performed with absorbable, monofilament, suture and skin will be closed using staples or suture at the discretion of the surgeon. | Procedure or surgery | Surgical Gastrojejunostomy |
| Gastric Outlet Obstruction Scoring System (GOOSS)A previously validated instrument for assessing tolerance of oral intake. | Other | EUS Gastrojejunostomy, Surgical Gastrojejunostomy |
Primary outcome
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy
Time frame: 1 day post-operative
A GOOSS score of 0 will be defined as intolerant of oral intake, while any GOOSS score greater than 0 will be defined as tolerant of oral intake. 0: no oral intake 1. oral liquids only 2. soft solids 3. low residue or full diet This will be given to subjects
Compare post procedure length of hospital stay
Time frame: 14 days post-operative
This outcome will be measured as the length of hospital stay (in days) from study intervention to discharge. Any accrued hospital stay from admission prior to study intervention will not be included in this assessment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Patrick Yachimski, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing EUS Gastrojejunostomy, Surgical Gastrojejunostomy and Gastric Outlet Obstruction Scoring System (GOOSS) in people with Malignant Gastric Outlet Obstruction, run by Vanderbilt University Medical Center.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy (time frame: 1 day post-operative). The study lists 2 primary outcomes in all. 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 27 Oct 2026.