Malignant Gastric Outlet ObstructionNCT07896577
Prophylactic PPI Use After EUS-GE Procedure
A study testing Esomeprazole in people with Malignant Gastric Outlet Obstruction, run by Changhai Hospital.
Trial summary
This study aims to compare the 6-month cumulative incidence of mucosal erosion or ulcer involving the anastomosis and LAMS flange in patients with and without 6-month prophylactic PPI treatment following EUS-GE, and to assess whether routine PPI use provides clear mucosal-protective effects 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?
- Esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2027
- 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
- Aged ≥18 years, male or female, with no gender restriction.
- Planned for EUS-GE for malignant gastric outlet obstruction (GOO).
- Technically successful EUS-GE: correct stent position is intra-operatively confirmed comprehensively via fluoroscopy-aided contrast injection through the stent and dye solution flowing into the stomach through the stent; no severe adverse events requiring urgent surgical or interventional management occur during the procedure.
- Planned LAMS indwelling for at least 6 months, and willingness to undergo scheduled gastroscopy evaluations at 3-month and 6-month post-procedure.
- Able to take oral study medications per protocol after significant relief of obstructive symptoms.
- The subject or legal representative is fully informed and provides written informed consent
Who cannot join
- Definite indication for long-term proton-pump inhibitor (PPI) therapy that cannot be discontinued or de-escalated, including active peptic ulcer disease, recent upper gastrointestinal bleeding, Los Angeles grade C/D reflux esophagitis, Zollinger-Ellison syndrome, antithrombotic or NSAID therapy judged by the investigator to require continuous gastric mucosal protection, etc.
- Active gastric or duodenal ulcer, overt gastrointestinal bleeding within 7 days prior to enrollment, or unexplained persistent hemoglobin decline.
- Ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or high-dose glucocorticoids; or inability to adjust anticoagulant and antiplatelet agents per study protocol.
- INR > 1.5, platelet count < 50 × 10⁹/L, or other uncorrected severe coagulopathy.
- Severe cardiac, pulmonary, hepatic or renal insufficiency; pregnancy or lactation.
- Hypersensitivity to esomeprazole, other benzimidazole-class agents, or excipients.
- Concurrent participation in other interventional clinical trials that may affect the primary endpoint.
- Poor compliance judged by the investigator; inability to complete electronic medication records or scheduled gastroscopic follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Impact of Prophylactic Proton Pump Inhibitor Use Following Endoscopic-guided Gastrointestinal Anastomosis on Mucosal Injury at the Anastomotic Site
This study aims to compare the 6-month cumulative incidence of mucosal erosion or ulcer involving the anastomosis and LAMS flange in patients with and without 6-month prophylactic PPI treatment following EUS-GE, and to assess whether routine PPI use provides clear mucosal-protective effects
- Conditions
- Malignant Gastric Outlet Obstruction
- Being tested
- Esomeprazole, Placebo
- Keywords
- EUS-GE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Intravenous esomeprazole 40 mg (in 100 mL normal saline) on the day of procedure; after first oral intake, oral esomeprazole 20 mg twice daily, 30 min before meals, for 6 months.
PlaceboDrug
Intravenous infusion of 100 mL normal saline on the day of procedure; after first oral intake, matching placebo (identical appearance, odor, weight, packaging) twice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| PPI | Active comparator | use PPI after the procedure for 6 months to prevent potential ulceration Receives: Drug: Esomeprazole |
| non-PPI | Placebo comparator | Placebo use after the procedure for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucosal injury
anastomotic, gastric-side or jejunal-side erosion, ulcer, or associated bleeding
Measured: 6 months
Secondary outcomes (2)
Mechanical LAMS-related events
tissue hyperplasia, stent ingrowth, flange embedding, ≥25% reduction in LAMS luminal diameter, food impaction, stent deformation or migration
Measured: 6 months
reintervention
Any EUS-GE-related reintervention and time to first EUS-GE-related reintervention
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 posted27 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896577
- Sponsor's protocol ID
- ChanghaiH
- Other IDs
- 82570771,82070663
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Study on the Impact of Prophylactic Proton Pump Inhibitor Use Following Endoscopic-guided Gastrointestinal Anastomosis on Mucosal Injury at the Anastomotic Site
- ClinicalTrials.gov ID
- NCT07896577
- Acronym / sponsor ID
- ChanghaiH
- Conditions
- Malignant Gastric Outlet Obstruction
- Keywords
- EUS-GE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This study aims to compare the 6-month cumulative incidence of mucosal erosion or ulcer involving the anastomosis and LAMS flange in patients with and without 6-month prophylactic PPI treatment following EUS-GE, and to assess whether routine PPI use provides clear mucosal-protective effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI | Active comparator | Drug: Esomeprazoleuse PPI after the procedure for 6 months to prevent potential ulceration |
| non-PPI | Placebo comparator | Drug: PlaceboPlacebo use after the procedure for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years, male or female, with no gender restriction.
- Planned for EUS-GE for malignant gastric outlet obstruction (GOO).
- Technically successful EUS-GE: correct stent position is intra-operatively confirmed comprehensively via fluoroscopy-aided contrast injection through the stent and dye solution flowing into the stomach through the stent; no severe adverse events requiring urgent surgical or interventional management occur during the procedure.
- Planned LAMS indwelling for at least 6 months, and willingness to undergo scheduled gastroscopy evaluations at 3-month and 6-month post-procedure.
- Able to take oral study medications per protocol after significant relief of obstructive symptoms.
Key exclusion criteria (8 listed)
- Definite indication for long-term proton-pump inhibitor (PPI) therapy that cannot be discontinued or de-escalated, including active peptic ulcer disease, recent upper gastrointestinal bleeding, Los Angeles grade C/D reflux esophagitis, Zollinger-Ellison syndrome, antithrombotic or NSAID therapy judged by the investigator to require continuous gastric mucosal protection, etc.
- Active gastric or duodenal ulcer, overt gastrointestinal bleeding within 7 days prior to enrollment, or unexplained persistent hemoglobin decline.
- Ongoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or high-dose glucocorticoids; or inability to adjust anticoagulant and antiplatelet agents per study protocol.
- INR > 1.5, platelet count < 50 × 10⁹/L, or other uncorrected severe coagulopathy.
- Severe cardiac, pulmonary, hepatic or renal insufficiency; pregnancy or lactation.
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 |
|---|---|---|
| EsomeprazoleIntravenous esomeprazole 40 mg (in 100 mL normal saline) on the day of procedure; after first oral intake, oral esomeprazole 20 mg twice daily, 30 min before meals, for 6 months. | Drug | PPI |
| PlaceboIntravenous infusion of 100 mL normal saline on the day of procedure; after first oral intake, matching placebo (identical appearance, odor, weight, packaging) twice daily for 6 months. | Drug | non-PPI |
Primary outcome
mucosal injury
Time frame: 6 months
anastomotic, gastric-side or jejunal-side erosion, ulcer, or associated bleeding
2 secondary outcomes
Mechanical LAMS-related events
Time frame: 6 months
reintervention
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 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.
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole in people with Malignant Gastric Outlet Obstruction, run by Changhai Hospital.
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 6 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: opening soon, 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. Some participants in this study may receive a placebo. 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?
Contact JiaYi Ma, medical doctor (+86-13621819595, 504043536@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mucosal injury (time frame: 6 months). 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.