Gastric Outlet ObstructionNCT05548114
Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
A study testing EUS-guided gastrojejunostomy and Surgical gastrojejunostomy in people with Gastric Outlet Obstruction, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- EUS-guided gastrojejunostomy and Surgical gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2022to Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
- Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
- Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
Who cannot join
- Age < 18 years
- Intrauterine pregnancy
- Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
- Unable to obtain consent for the procedure from either the patient or LAR
- Altered anatomy due to prior gastroduodenal surgery
- Presence of other adhesions or synchronous obstructive lesions in the small bowel
- Prior treatment for gastric outlet obstruction
- Presence of large volume malignant ascites
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Read the detailed description
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- EUS-guided gastrojejunostomy, Surgical gastrojejunostomy
- Keywords
- Gastric outlet obstruction, Endoscopic ultrasound, Surgery, Malignancy, Gastrojejunostomy
- Medical subject headings
- Gastric Outlet Obstruction, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided gastrojejunostomyProcedure or surgery
AXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance.
Surgical gastrojejunostomyProcedure or surgery
A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided gastrojejunostomy | Active comparator | EUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent Receives: Procedure: EUS-guided gastrojejunostomy |
| Surgical gastrojejunostomy | Active comparator | A surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate. Receives: Procedure: Surgical gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Measured: 6 months
Secondary outcomes (16)
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Measured: 6 months
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Proportion of patients with Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Measured: 6 months
Rate of technical success
Technical success is defined as the successful creation of a gastrojejunal anastomosis by the originally assigned method.
Measured: 24 hours
Procedure duration
Procedure duration for EUS-guided and surgical gastrojejunostomy procedures
Measured: 24 hours
Time to diet advancement
Time to liquid diet (GOOSS score 1), soft solid diet (GOOSS score 2) and regular solid diet (GOOSS score 3).
Measured: 1 month
Time to recurrence of obstructive symptoms
Recurrence of obstructive symptoms, defined as the recurrence of obstructive symptoms (GOOSS score ≤ 1) after achieving GOOSS ≥ 2 for at least 7 days at any time during follow-up.
Measured: 6 months
Rate of persistence of symptoms
Persistent of obstructive symptoms, defined as continuing symptoms up to 2 weeks after index procedure.
Measured: 6 months
Rate of reintervention
Reintervention, defined as need for repeat treatment for persistent or recurrent obstructive symptoms. Reintervention can be any endoscopic or surgical therapy.
Measured: 6 months
Total number of readmissions
Total no. of readmissions due to disease-related symptoms or procedure-related events.
Measured: 6 months
Rate of adverse events due to procedures performed
Procedure-related adverse events
Measured: 6 months
Rate of adverse events due to underlying disease
Disease-related adverse events
Measured: 6 months
Total length of hospital stay
Duration of hospitalization, defined as the length of hospital stay from the date of the procedure to the date of discharge.
Measured: 6 months
Length of survival
Duration of survival post-procedure.
Measured: 6 months
Time to initiation of chemotherapy post-procedure
Time to initiation of chemotherapy post-procedure
Measured: 6 months
Quality of life measurement
Quality of life post-procedure as determined by the EORTC-QLQ-C30 quality of life questionnaire.
Measured: 6 months
Treatment costs
All relevant costs pertaining to treatment of gastric outlet obstruction will be taken into consideration from index intervention to hospital discharge: procedure costs, inpatient hospital stay from date of procedure to discharge, medications, materials, anesthesia, pharmacy and imaging studies.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start16 Sep 2022
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University, Rush University, Asian Institute of Gastroenterology, India, Medanta, The Medicity, India, University of Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Ji Young Bang, MD MPH, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548114
- Sponsor's protocol ID
- 22.127.06
- Status last verified
- Mar 2025
- First submitted
- 16 Sep 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bang JY, Puri R, Lakhtakia S, Thakkar S, Waxman I, Siddiqui I, Arnold K, Chaudhary A, Mehta S, Singh A, Venkat Rao G, Basha J, Gupta R, Modak S, Singh S, Boone B, Dautel P, Dixon MEB, Kim HM, Sutton B, Arnoletti JP, Rosch T, Varadarajulu S. Endoscopic or surgical gastroenterostomy for malignant gastric outlet obstruction: a randomised trial. Gut. 2025 Dec 5;75(1):24-32. doi: 10.1136/gutjnl-2025-336339.
PubMed 40998416
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction
- ClinicalTrials.gov ID
- NCT05548114
- Acronym / sponsor ID
- 22.127.06
- Conditions
- Gastric Outlet Obstruction
- Keywords
- Gastric outlet obstruction, Endoscopic ultrasound, Surgery, Malignancy, Gastrojejunostomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Collaborators
- West Virginia University, Rush University, Asian Institute of Gastroenterology, India, Medanta, The Medicity, India, University of Hamburg-Eppendorf
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Sep 2022 (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.
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Detailed description
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided gastrojejunostomy | Active comparator | Procedure: EUS-guided gastrojejunostomyEUS-guided gastrojejunostomy is performed using a lumen-apposing metal stent |
| Surgical gastrojejunostomy | Active comparator | Procedure: Surgical gastrojejunostomyA surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
- Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
- Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
Key exclusion criteria (8 listed)
- Age < 18 years
- Intrauterine pregnancy
- Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
- Unable to obtain consent for the procedure from either the patient or LAR
- Altered anatomy due to prior gastroduodenal surgery
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 gastrojejunostomyAXIOS lumen-apposing metal stent will be used to create a gastrojejunostomy under EUS guidance. | Procedure or surgery | EUS-guided gastrojejunostomy |
| Surgical gastrojejunostomyA surgical gastrojejunostomy will be created via laparoscopic or robotic techniques (preferred) or open technique (if these methods fail), as clinically appropriate. | Procedure or surgery | Surgical gastrojejunostomy |
Primary outcome
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
Time frame: 6 months
Proportion of patients unable to tolerate a solid diet at time of hospital discharge (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.
16 secondary outcomes
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 1-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time frame: 6 months
Gastric Outlet Obstruction Scoring System (GOOSS) score of ≥ 2 at 6-month post-procedure, without the need for repeat intervention or supplemental nutrition such as the use of enteric feeding tubes or total parenteral nutrition (TPN).
Time frame: 6 months
Rate of technical success
Time frame: 24 hours
Procedure duration
Time frame: 24 hours
Time to diet advancement
Time frame: 1 month
Time to recurrence of obstructive symptoms
Time frame: 6 months
Rate of persistence of symptoms
Time frame: 6 months
Rate of reintervention
Time frame: 6 months
Total number of readmissions
Time frame: 6 months
Rate of adverse events due to procedures performed
Time frame: 6 months
Rate of adverse events due to underlying disease
Time frame: 6 months
Total length of hospital stay
Time frame: 6 months
Length of survival
Time frame: 6 months
Time to initiation of chemotherapy post-procedure
Time frame: 6 months
Quality of life measurement
Time frame: 6 months
Treatment costs
Time frame: 6 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 12 Jun 2025.
- Derived from this study: PubMed 40998416Bang JY, Puri R, Lakhtakia S, Thakkar S, Waxman I, Siddiqui I, Arnold K, Chaudhary A, Mehta S, Singh A, Venkat Rao G, Basha J, Gupta R, Modak S, Singh S, Boone B, Dautel P, Dixon MEB, Kim HM, Sutton B, Arnoletti JP, Rosch T, Varadarajulu S. Endoscopic or surgical gastroenterostomy for malignant gastric outlet obstruction: a randomised trial. Gut. 2025 Dec 5;75(1):24-32. doi: 10.1136/gutjnl-2025-336339.
- 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.
Ji Young Bang, MD MPH principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided gastrojejunostomy and Surgical gastrojejunostomy in people with Gastric Outlet Obstruction, run by Orlando Health, Inc. at 1 site in United States.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 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 United States. 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?
Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events. (time frame: 6 months). 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 NCT05548114, 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 12 Jun 2025.