Trial Outcomes & Findings for EUS-GE vs ES for Palliation of Gastric Outlet Obstruction (NCT NCT03259763)
NCT ID: NCT03259763
Last Updated: 2026-07-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
12 months
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
|
Overall Study
Included in Primary Analysis
|
56
|
52
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
50
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two patients in the ES group had missing data.
Baseline characteristics by cohort
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 Participants
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.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Years
n=57 Participants
|
63 Years
n=55 Participants
|
63 Years
n=112 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=57 Participants • Two patients in the ES group had missing data.
|
17 Participants
n=53 Participants • Two patients in the ES group had missing data.
|
46 Participants
n=110 Participants • Two patients in the ES group had missing data.
|
|
Sex: Female, Male
Male
|
28 Participants
n=57 Participants • Two patients in the ES group had missing data.
|
36 Participants
n=53 Participants • Two patients in the ES group had missing data.
|
64 Participants
n=110 Participants • Two patients in the ES group had missing data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=57 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=57 Participants
|
25 Participants
n=55 Participants
|
50 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=57 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=57 Participants
|
9 Participants
n=55 Participants
|
18 Participants
n=112 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=57 Participants
|
18 Participants
n=55 Participants
|
39 Participants
n=112 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=57 Participants
|
0 Participants
n=55 Participants
|
0 Participants
n=112 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=57 Participants
|
3 Participants
n=55 Participants
|
5 Participants
n=112 Participants
|
|
Malignancy Diagnosis
Pancreatic Cancer
|
24 Participants
n=57 Participants
|
25 Participants
n=55 Participants
|
49 Participants
n=112 Participants
|
|
Malignancy Diagnosis
Gastric Carcinoma
|
3 Participants
n=57 Participants
|
10 Participants
n=55 Participants
|
13 Participants
n=112 Participants
|
|
Malignancy Diagnosis
Duodenal or Ampullary Cancer
|
11 Participants
n=57 Participants
|
6 Participants
n=55 Participants
|
17 Participants
n=112 Participants
|
|
Malignancy Diagnosis
Other
|
19 Participants
n=57 Participants
|
14 Participants
n=55 Participants
|
33 Participants
n=112 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group.
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.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=56 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=52 Participants
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
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
15.4 Percentage of Participants
Interval 5.3 to 25.4
|
SECONDARY outcome
Timeframe: Day of procedureParticipants with adequate positioning and deployment of the stent(s) as determined endoscopically and radiographically.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 Participants
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.
|
|---|---|---|
|
Technical Success Rate
|
56 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 1 weekParticipants 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.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 Participants
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.
|
|---|---|---|
|
Participants With Improved Clinical Success Rate
|
50 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Day of procedurePopulation: Participants with data collected
Duration of the procedure (minutes)
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=52 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=52 Participants
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.
|
|---|---|---|
|
Length of Procedure
|
24.3 Minutes
Standard Deviation 12.5
|
15.8 Minutes
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 12 monthsParticipants with Adverse events based on ASGE Lexicon
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 Participants
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.
|
|---|---|---|
|
Participants With Adverse Events
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Participants with data collected
Duration of hospitalization following the procedure, measured in days from the date of the procedure to the date of hospital discharge.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=42 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=41 Participants
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.
|
|---|---|---|
|
Post-procedure Length of Hospital Stay
|
0.7 days
Standard Deviation 0.6
|
0.9 days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group.
Reintervention (endoscopic or surgical) for stent dysfunction causing recurrent gastric outlet obstruction
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=56 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=52 Participants
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.
|
|---|---|---|
|
Reintervention Rate for Recurrent Gastric Outlet Obstruction
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
15.4 Percentage of Participants
Interval 5.4 to 25.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants with data collected
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.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=28 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=27 Participants
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.
|
|---|---|---|
|
Quality of Life SF-36 Questionnaire Scoring
Energy/fatigue
|
41.1 Baseline adjusted mean score
Interval 34.7 to 47.4
|
44.9 Baseline adjusted mean score
Interval 38.5 to 51.4
|
|
Quality of Life SF-36 Questionnaire Scoring
General health
|
48.4 Baseline adjusted mean score
Interval 41.3 to 55.5
|
41.4 Baseline adjusted mean score
Interval 34.4 to 48.5
|
|
Quality of Life SF-36 Questionnaire Scoring
Physical functioning
|
38.7 Baseline adjusted mean score
Interval 29.5 to 48.0
|
44.1 Baseline adjusted mean score
Interval 34.9 to 53.3
|
|
Quality of Life SF-36 Questionnaire Scoring
Role limitations due to physical problems
|
28.7 Baseline adjusted mean score
Interval 16.8 to 40.6
|
19.0 Baseline adjusted mean score
Interval 7.0 to 30.9
|
|
Quality of Life SF-36 Questionnaire Scoring
Role limitations due to emotional problems
|
32.8 Baseline adjusted mean score
Interval 19.5 to 46.1
|
31.5 Baseline adjusted mean score
Interval 18.2 to 44.8
|
|
Quality of Life SF-36 Questionnaire Scoring
Emotional well-being
|
67.7 Baseline adjusted mean score
Interval 62.5 to 72.9
|
65.3 Baseline adjusted mean score
Interval 59.9 to 70.6
|
|
Quality of Life SF-36 Questionnaire Scoring
Social functioning
|
56.9 Baseline adjusted mean score
Interval 49.2 to 64.6
|
52.8 Baseline adjusted mean score
Interval 45.1 to 60.5
|
|
Quality of Life SF-36 Questionnaire Scoring
Bodily pain
|
55.9 Baseline adjusted mean score
Interval 48.1 to 63.8
|
56.9 Baseline adjusted mean score
Interval 49.0 to 64.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients without post-randomization follow-up data collected were excluded from time-to-event analyses (1 in EUS-GE group and 3 in ES group.
Percentage of participants surviving at 12 months after randomization, regardless of cause of death.
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=56 Participants
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=52 Participants
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.
|
|---|---|---|
|
Overall Survival Rate
|
15.6 Percentage of Participants
Interval 8.2 to 29.9
|
13.5 Percentage of Participants
Interval 6.8 to 26.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only participants with recurrent gastric outlet obstruction due to stent dysfunction were included in the analyses. Eight patients in the ES group had recurrent gastric outlet obstruction, but there was no recurrence of gastric outlet obstruction in the EUS-GE group.
Time from the procedure to the start of recurrent gastric outlet obstruction symptoms and signs due to stent dysfunction
Outcome measures
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=8 Participants
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.
|
|---|---|---|
|
Time in Days to Recurrent Gastric Outlet Obstruction
|
—
|
149 days
Interval 7.0 to 252.0
|
Adverse Events
EUS-guided Gastroenterostomy (EUS-GE)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 44 deaths
Enteral Stenting (ES)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 participants at risk
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Perforation
|
0.00%
0/57 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
1.8%
1/55 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
|
Gastrointestinal disorders
Stent migration
|
0.00%
0/57 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
1.8%
1/55 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/57 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
1.8%
1/55 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
Other adverse events
| Measure |
EUS-guided Gastroenterostomy (EUS-GE)
n=57 participants at risk
In this technique, a lumen-apposing metal stent is deployed between the gastric wall and its adjacent small intestine to keep the stomach-small intestine connection open.
|
Enteral Stenting (ES)
n=55 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Emesis
|
1.8%
1/57 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
1.8%
1/55 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
|
Gastrointestinal disorders
Stent misdeployment
|
1.8%
1/57 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
0.00%
0/55 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
|
Gastrointestinal disorders
Stent-related pressure ulceration
|
1.8%
1/57 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
0.00%
0/55 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • Number of events 1 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
0.00%
0/55 • Up to 12 months
Adverse events were reported based on ASGE Lexicon
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place