Could a simple drug combo speed up stomach ulcer healing after cancer surgery?

NCT ID NCT07312370

Disease control Sponsor: LanZhou University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether adding sucralfate (a protective coating agent) to standard esomeprazole (a stomach acid reducer) helps heal artificial ulcers created during endoscopic surgery for early stomach cancer or precancerous growths. About 120 adults will be randomly assigned to get either the combo or esomeprazole alone for 8 weeks. The main goal is to see how much the ulcer shrinks after 4 weeks, and whether the combo reduces bleeding and other complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Esomeprazole and sucralfate suspension
What this could lead to: If successful, this combination could become a standard treatment to help stomach ulcers heal faster and reduce bleeding after endoscopic surgery for early gastric cancer.
What could go wrong: This is a small, early-phase trial with only 120 participants, so results may not apply to everyone. Adding sucralfate may not provide significant benefit over esomeprazole alone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-80 years, male or female 2. Diagnosed with early gastric cancer or high-grade intraepithelial neoplasia planned for gastric ESD 3. Lesion location: Gastric corpus, antrum, or angle (cardiac lesions may be included but will require subgroup analysis) 4. Successful en bloc resection achieved by ESD 5. Post-ESD artificial ulcer diameter ≥2 cm 6. Complete coagulation of all visible vessels during ESD procedure 7. ECOG performance status 0-1 8. Able to comply with follow-up visits and endoscopic examinations 9. Voluntary participation with written informed consent Exclusion Criteria: 1. Previous gastric surgery history 2. Active peptic ulcer disease (confirmed by pre-ESD endoscopy) within 1 month 3. Recent upper gastrointestinal bleeding (within 1 month, excluding tumor-related bleeding) 4. Severe heart, liver, or kidney dysfunction (Child-Pugh class C, NYHA class III-IV, or CKD stage 4-5) 5. Coagulation disorders (INR \>1.5 or platelet count \<50×10⁹/L) 6. Uncontrolled diabetes (HbA1c \>9%) 7. Known allergy or hypersensitivity to PPIs or sucralfate 8. Use of PPIs, H2 receptor antagonists, or mucosal protective agents within 2 weeks prior to ESD 9. Long-term anticoagulant therapy that cannot be discontinued (e.g., warfarin, direct oral anticoagulants) 10. Long-term NSAIDs or aspirin (\>100mg/day) that cannot be discontinued 11. Unsuccessful complete (en bloc) resection (piecemeal resection) 12. Intraoperative perforation 13. Uncontrolled active bleeding during ESD 14. Pregnancy or lactation 15. Women of childbearing potential not using adequate contraception 16. Concurrent participation in another clinical trial 17. Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation

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Conditions

The condition(s) this trial relates to.

active peptic ulcer disease gastric neoplasm gastric ulcer intraepithelial neoplasia microinvasive gastric cancer peptic ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early gastric cancer Gastric dysplasia Gastric neoplasms Gastric ulcer Peptic ulcer with haemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a simple drug combo speed up stomach ulcer healing after cancer surgery?

What the study statuses mean