Early Gastric Cancer, Gastric Dysplasia, Gastric Neoplasms, Gastric Ulcer, Peptic Ulcer With Haemorrhage
Conditions
Keywords
Endoscopic Submucosal Dissection, Gastric Cancer, Ulcer Healing, Proton Pump Inhibitor, Post-ESD Ulcer, Early Gastric Neoplasm
Brief summary
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.
Interventions
DRUGEsomeprazole (Intravenous)
Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
DRUGEsomeprazole (Oral)
Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
DRUGSucralfate Suspension
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).
PROCEDUREGastric Endoscopic Submucosal Dissection (ESD)
Standardized gastric ESD procedure including lesion marking, submucosal injection, circumferential incision, submucosal dissection, and complete coagulation of all visible vessels at the ulcer base.
Sponsors
LanZhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open-label study for participants and care providers due to the nature of oral suspension that cannot be easily matched with placebo. However, outcome assessors (endoscopists evaluating images and videos) and data analysts will be blinded to treatment allocation until database lock.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Reduction Rate at 4 Weeks Post-ESD | 4 weeks after ESD procedure (±3 days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Reduction Rate at 8 Weeks Post-ESD | 8 weeks after ESD procedure (±3 days) | Same calculation method as primary outcome, assessed at 8 weeks |
| Ulcer Stage at 4 Weeks (Sakita Classification) | 4 weeks after ESD procedure (±3 days) | 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 | 8 weeks after ESD procedure (±3 days) | 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 | From 24 hours post-ESD up to 8 weeks | 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. |
| Change in Epigastric Pain Score | Baseline (Day 0), Day 7, Week 4, and Week 8 | 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. |
| Change in Bloating Score | Baseline (Day 0), Day 7, Week 4, and Week 8 | 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. |
| Change in Acid Reflux Score | Baseline (Day 0), Day 7, Week 4, and Week 8 | 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. |
| Change in Quality of Life Score | Baseline (Day 0), Week 4, and Week 8 | 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. |
| Rate of Rehospitalization Due to ESD-Related Complications | From Day 0 through Week 8 | Proportion of patients requiring rehospitalization due to post-ESD complications including delayed bleeding, severe pain, or other ESD-related adverse events |
| Need for Endoscopic Hemostatic Intervention | From Day 0 through Week 8 | Proportion of patients requiring emergency or urgent endoscopic hemostatic procedures (such as hemoclipping, coagulation, or injection therapy) for post-ESD bleeding |
| Incidence of Adverse Events | From Day 0 through Week 8 | 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 |
| Medication Compliance Rate | Throughout 8-week treatment period | 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. |
Countries
China
Contacts
CONTACTQiangqiang Tian
CONTACTZhaofeng Chen
Outcome results
None listed