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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
Sucralfate 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).
Standardized gastric ESD procedure including lesion marking, submucosal injection, circumferential incision, submucosal dissection, and complete coagulation of all visible vessels at the ulcer base.
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
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
Time frame: 4 weeks after ESD procedure (±3 days)
Ulcer Reduction Rate at 8 Weeks Post-ESD
Same calculation method as primary outcome, assessed at 8 weeks
Time frame: 8 weeks after ESD procedure (±3 days)
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.
Time frame: 4 weeks after ESD procedure (±3 days)
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
Time frame: 8 weeks after ESD procedure (±3 days)
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.
Time frame: From 24 hours post-ESD up to 8 weeks
Change in Epigastric Pain Score
Severity of epigastric pain assessed using Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Change from baseline at each time point will be calculated.
Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8
Change in Bloating Score
Severity of bloating assessed using Visual Analog Scale (VAS) ranging from 0 (no bloating) to 10 (worst imaginable bloating). Change from baseline at each time point will be calculated.
Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8
Change in Acid Reflux Score
Severity of acid reflux assessed using Visual Analog Scale (VAS) ranging from 0 (no reflux) to 10 (worst imaginable reflux). Change from baseline at each time point will be calculated.
Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8
Change in Quality of Life Score
Quality of life assessed using EQ-5D-5L questionnaire, which evaluates five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five levels each, plus a visual analog scale (0-100). Change from baseline will be calculated.
Time frame: Baseline (Day 0), Week 4, and Week 8
Rate of Rehospitalization Due to ESD-Related Complications
Proportion of patients requiring rehospitalization due to post-ESD complications including delayed bleeding, severe pain, or other ESD-related adverse events
Time frame: From Day 0 through Week 8
Need for Endoscopic Hemostatic Intervention
Proportion of patients requiring emergency or urgent endoscopic hemostatic procedures (such as hemoclipping, coagulation, or injection therapy) for post-ESD bleeding
Time frame: From Day 0 through Week 8
Incidence of Adverse Events
Frequency and severity of all adverse events and serious adverse events, categorized by organ system and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From Day 0 through Week 8
Medication Compliance Rate
Percentage of prescribed medication doses actually taken by the patient, calculated as: (Actual medication days / Expected medication days) × 100%. Assessed using medication diary and pill/sachet count. Compliance ≥80% will be considered good.
Time frame: Throughout 8-week treatment period
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