An interventional study of Lumen-apposing metal stent and Self-expandable metal stent in Gastric Outlet Obstruction, sponsored by Johns Hopkins University. Completed at 9 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).
In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions.
Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions.
38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.
This study's enrollment of 112 is above the median of 69 across 28 interventional studies indexed under Gastric Outlet Obstruction.
Browse Gastric Outlet Obstruction studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
Device: Lumen-apposing metal stent
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
Device: Self-expandable metal stent
In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.
In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.
Percentage of Participants With Gastric Outlet Obstruction Recurrence
Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically.
Time frame: 12 months
Technical Success Rate
Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Time frame: Day of procedure
Participants With Improved Clinical Success Rate
Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better.
Time frame: 1 week
Length of Procedure
Duration of the procedure (minutes)
Time frame: Day of procedure
Participants With Adverse Events
Participants with Adverse events based on ASGE Lexicon
Time frame: 12 months
Post-procedure Length of Hospital Stay
Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.
Time frame: 1 week
Reintervention Rate for Recurrent Gastric Outlet Obstruction
Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction
Time frame: 12 months
Quality of Life SF-36 Questionnaire Scoring
The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
Time frame: 3 months
Overall Survival Rate
Percentage of participants surviving at 12 months after randomization, regardless of cause of death.
Time frame: 1 year
Time in Days to Recurrent Gastric Outlet Obstruction
Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction
Time frame: 12 months
| Milestone | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Started | 57 | 55 |
| Included in primary analysis | 56 | 52 |
| Completed | 7 | 7 |
| Not completed | 50 | 48 |
Defined as percentage of participants with recurrence of nausea, vomiting, and inability to tolerate PO intake up to 12 months after the procedure confirmed either endoscopically and/or radiographically.
| Percentage of Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Percentage of Participants With Gastric Outlet Obstruction Recurrence | 0 (0 to 0) | 15.4 (5.3 to 25.4) |
Participants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
| Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Technical Success Rate | 56 | 52 |
Participants with improvement of at least 1 point in the gastric outlet obstruction score range 0-3 (0 as no oral intake to 3 as complete diet) within 7 days after stent insertion. Higher score better.
| Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Participants With Improved Clinical Success Rate | 50 | 42 |
Duration of the procedure (minutes)
| Minutes | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Length of Procedure | 24.3 ± 12.5 | 15.8 ± 8.1 |
Participants with Adverse events based on ASGE Lexicon
| Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Participants With Adverse Events | 4 | 4 |
Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.
| days | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Post-procedure Length of Hospital Stay | 0.7 ± 0.6 | 0.9 ± 1.5 |
Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction
| Percentage of Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Reintervention Rate for Recurrent Gastric Outlet Obstruction | 0 (0 to 0) | 15.4 (5.4 to 25.4) |
The SF-36 general health questionnaire consists of 36 questions evaluating the patient's perception of their quality of life (QoL) in the following eight subscales: physical functioning (PF), role limitations due to physical problems (RP), role limitations due to emotional problems (RE), energy/fatigue (EF), emotional well-being (EW), social functioning (SF), bodily pain (BP) and general health (GH). Subscale scores range from 0 to 100, with 100 being the best and 0 being the worst quality of life.
| Baseline adjusted mean score | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Physical functioning | 38.7 (29.5 to 48.0) | 44.1 (34.9 to 53.3) |
| Role limitations due to physical problems | 28.7 (16.8 to 40.6) | 19.0 (7.0 to 30.9) |
| Role limitations due to emotional problems | 32.8 (19.5 to 46.1) | 31.5 (18.2 to 44.8) |
| Energy/fatigue | 41.1 (34.7 to 47.4) | 44.9 (38.5 to 51.4) |
| Emotional well-being | 67.7 (62.5 to 72.9) | 65.3 (59.9 to 70.6) |
| Social functioning | 56.9 (49.2 to 64.6) | 52.8 (45.1 to 60.5) |
| Bodily pain | 55.9 (48.1 to 63.8) | 56.9 (49.0 to 64.7) |
| General health | 48.4 (41.3 to 55.5) | 41.4 (34.4 to 48.5) |
Percentage of participants surviving at 12 months after randomization, regardless of cause of death.
| Percentage of Participants | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Overall Survival Rate | 15.6 (8.2 to 29.9) | 13.5 (6.8 to 26.8) |
Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction
| days | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| Time in Days to Recurrent Gastric Outlet Obstruction | — | 149 (7 to 252) |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EUS-guided Gastroenterostomy (EUS-GE) | 44/57 (77.2%) | 0/57 (0%) | 4/57 (7%) |
| Enteral Stenting (ES) | 45/55 (81.8%) | 3/55 (5.5%) | 1/55 (1.8%) |
| Event | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| PerforationGastrointestinal disorders | 0/57 | 1/55 |
| Stent migrationGastrointestinal disorders | 0/57 | 1/55 |
| AspirationRespiratory, thoracic and mediastinal disorders | 0/57 | 1/55 |
| Event | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) |
|---|---|---|
| EmesisGastrointestinal disorders | 1/57 | 1/55 |
| Stent misdeploymentGastrointestinal disorders | 1/57 | 0/55 |
| Stent-related pressure ulcerationGastrointestinal disorders | 1/57 | 0/55 |
| DiarrheaGastrointestinal disorders | 1/57 | 0/55 |
| Age, Continuous(Years) | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) | Total |
|---|---|---|---|
| Median | 63 (56 to 69) | 63 (59 to 70) | 63 (58 to 69) |
| Sex: Female, Male(Participants) | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) | Total |
|---|---|---|---|
| Female | 29 | 17 | 46 |
| Male | 28 | 36 | 64 |
| Race (NIH/OMB)(Participants) | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 25 | 25 | 50 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 9 | 18 |
| White | 21 | 18 | 39 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Malignancy Diagnosis(Participants) | EUS-guided Gastroenterostomy (EUS-GE) | Enteral Stenting (ES) | Total |
|---|---|---|---|
| Pancreatic Cancer | 24 | 25 | 49 |
| Gastric Carcinoma | 3 | 10 | 13 |
| Duodenal or Ampullary Cancer | 11 | 6 | 17 |
| Other | 19 | 14 | 33 |
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