Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing: A Randomized Controlled Trial (ESUS-ESD)

Lanzhou University

Status and phase: Not yet enrolling; Phase 4

Conditions: Early Gastric Cancer; Gastric Ulcer; Gastric Neoplasms; Peptic Ulcer With Haemorrhage; Gastric Dysplasia

Treatments: Drug: Sucralfate Suspension; Drug: Esomeprazole (Oral); Procedure: Gastric Endoscopic Submucosal Dissection (ESD); Drug: Esomeprazole (Intravenous)

Study type: Interventional

Funder types: Other

Identifiers

NCT07312370

LDYYczf2025121701

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Esomeprazole + Sucralfate (Intervention Group)

Experimental group

Description:

* Days 1-3: Esomeprazole 40mg intravenously every 12 hours * Days 4-56: Esomeprazole 40mg orally once daily (before breakfast) + Sucralfate suspension 1g orally twice daily (1 hour before breakfast and at bedtime on empty stomach)

Treatment:

Drug: Esomeprazole (Intravenous)

Procedure: Gastric Endoscopic Submucosal Dissection (ESD)

Drug: Esomeprazole (Oral)

Drug: Sucralfate Suspension

Esomeprazole Alone (Control Group)

Active Comparator group

Description:

* Days 1-3: Esomeprazole 40mg intravenously every 12 hours * Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)

Treatment:

Drug: Esomeprazole (Intravenous)

Procedure: Gastric Endoscopic Submucosal Dissection (ESD)

Drug: Esomeprazole (Oral)