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.
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
Previous gastric surgery history
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)
Parallel
Esomeprazole (Intravenous)
DrugEsomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
Esomeprazole (Oral)
DrugEsomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
Sucralfate Suspension
DrugSucralfate suspension 1g (one sachet) orally twice daily for 8 weeks. Administered 1 hour before breakfast and at bedtime on empty stomach (2-3 hours after dinner). Should be taken separately from other medications (≥1-2 hours apart).
Gastric Endoscopic Submucosal Dissection (ESD)
Procedure/SurgeryStandardized gastric ESD procedure including lesion marking, submucosal injection, circumferential incision, submucosal dissection, and complete coagulation of all visible vessels at the ulcer base.
Ulcer Reduction Rate at 4 Weeks Post-ESD
The percentage reduction in ulcer area from baseline (immediately post-ESD) to 4 weeks, calculated as: Ulcer Reduction Rate (%) = \[(Baseline ulcer area - Week 4 ulcer area) / Baseline ulcer area\] × 100
Ulcer Reduction Rate at 8 Weeks Post-ESD
Same calculation method as primary outcome, assessed at 8 weeks
Ulcer Stage at 4 Weeks (Sakita Classification)
Classification of ulcer healing stage according to Sakita classification: A1 (active with thick coat), A2 (healing with thinning coat), H1 (healing with regenerating epithelium, red), H2 (healing with thickened epithelium, red fading), S1 (scar stage, red), S2 (scar stage, white). Assessed by blinded endoscopists.
Complete Ulcer Healing Rate at 8 Weeks
Proportion of patients achieving complete ulcer healing defined as scar stage (S1 or S2) on Sakita classification at 8 weeks post-ESD
Incidence of Delayed Bleeding
Occurrence of delayed post-ESD bleeding defined as: hematemesis or melena accompanied by hemoglobin decrease ≥2 g/dL, or requiring blood transfusion or endoscopic hemostatic intervention. Time of bleeding occurrence will be recorded.
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