NCT07312370Not yet recruitingPhase 4
Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing
Intravenous Esomeprazole Combined With Sucralfate Suspension for Ulcer Healing and Complication Prevention After Gastric Endoscopic Submucosal Dissection: A Prospective, Randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
Endoscopic submucosal dissection (ESD) is an established treatment for early gastric cancer and precancerous lesions. Post-ESD artificial ulcers may lead to complications including delayed bleeding (3-15%) and prolonged healing. Current guidelines recommend high-dose proton pump inhibitors (PPIs), but evidence for additional mucosal protective agents remains limited. This study aims to evaluate whether combining sucralfate suspension with standard intravenous esomeprazole therapy improves ulcer healing and reduces complications after gastric ESD compared to esomeprazole alone. This is a prospective, randomized, controlled, outcome-assessor-blinded trial. A total of 120 patients undergoing gastric ESD will be randomly assigned 1:1 to receive either: * Intervention group: Intravenous esomeprazole 40mg twice daily (3 days) followed by oral esomeprazole 40mg once daily PLUS sucralfate suspension 1g twice daily for 8 weeks * Control group: Intravenous esomeprazole 40mg twice daily (3 days) followed by oral esomeprazole 40mg once daily for 8 weeks The primary outcome is ulcer reduction rate at 4 weeks post-ESD, assessed by endoscopy. Secondary outcomes include complete ulcer healing rate at 8 weeks, delayed bleeding rate, symptom scores, and safety parameters. This study will provide high-quality evidence regarding the role of sucralfate as an adjunctive therapy for post-ESD ulcer management and may inform future clinical guidelines.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 20 Apr 2026
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- LanZhou University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07312370
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 20 Apr 2026 to the primary completion date, 20 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastric surgery history
- Use of PPIs, H2 receptor antagonists, or mucosal protective agents within 2 weeks prior to ESD
- Long-term anticoagulant therapy that cannot be discontinued (e.g., warfarin, direct oral anticoagulants)
- Unsuccessful complete (en bloc) resection (piecemeal resection)
- Concurrent participation in another clinical trial
Other illness
- Active peptic ulcer disease (confirmed by pre-ESD endoscopy) within 1 month
- Recent upper gastrointestinal bleeding (within 1 month, excluding tumor-related bleeding)
- Severe heart, liver, or kidney dysfunction (Child-Pugh class C, NYHA class III-IV, or CKD stage 4-5)
- Known allergy or hypersensitivity to PPIs or sucralfate
- Intraoperative perforation
- Uncontrolled active bleeding during ESD
- Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation
Lab values
- Coagulation disorders (INR \>1.5 or platelet count \<50×10⁹/L)
- Uncontrolled diabetes (HbA1c \>9%)
Other
- Long-term NSAIDs or aspirin (\>100mg/day) that cannot be discontinued
- Pregnancy or lactation
- Women of childbearing potential not using adequate contraception
Who the study is looking for
- Age 18-80 years, male or female
- Diagnosed with early gastric cancer or high-grade intraepithelial neoplasia planned for gastric ESD
- Lesion location: Gastric corpus, antrum, or angle (cardiac lesions may be included but will require subgroup analysis)
- Successful en bloc resection achieved by ESD
- Post-ESD artificial ulcer diameter ≥2 cm
- Complete coagulation of all visible vessels during ESD procedure
- ECOG performance status 0-1
- Able to comply with follow-up visits and endoscopic examinations
- Voluntary participation with written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.