Intravenous Esomeprazole Combined With Sucralfate Suspension for Ulcer Healing and Complication Prevention After Gastric Endoscopic Submucosal Dissection: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Ulcer Reduction Rate at 4 Weeks Post-ESD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Coagulation disorders (INR >1.5 or platelet count <50×10⁹/L)
- •Uncontrolled diabetes (HbA1c >9%)
- •Known allergy or hypersensitivity to PPIs or sucralfate
- •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)
- •Long-term NSAIDs or aspirin (>100mg/day) that cannot be discontinued
- •Unsuccessful complete (en bloc) resection (piecemeal resection)
- •Intraoperative perforation
- •Uncontrolled active bleeding during ESD
- •Pregnancy or lactation
- •Women of childbearing potential not using adequate contraception
- •Concurrent participation in another clinical trial
- •Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation
研究组 & 干预措施
Esomeprazole + Sucralfate (Intervention Group)
- 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)
干预措施: Esomeprazole (Intravenous) (Drug)
Esomeprazole + Sucralfate (Intervention Group)
- 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)
干预措施: Esomeprazole (Oral) (Drug)
Esomeprazole + Sucralfate (Intervention Group)
- 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)
干预措施: Sucralfate Suspension (Drug)
Esomeprazole + Sucralfate (Intervention Group)
- 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)
干预措施: Gastric Endoscopic Submucosal Dissection (ESD) (Procedure)
Esomeprazole Alone (Control Group)
- Days 1-3: Esomeprazole 40mg intravenously every 12 hours
- Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)
干预措施: Esomeprazole (Intravenous) (Drug)
Esomeprazole Alone (Control Group)
- Days 1-3: Esomeprazole 40mg intravenously every 12 hours
- Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)
干预措施: Esomeprazole (Oral) (Drug)
Esomeprazole Alone (Control Group)
- Days 1-3: Esomeprazole 40mg intravenously every 12 hours
- Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)
干预措施: Gastric Endoscopic Submucosal Dissection (ESD) (Procedure)
结局指标
主要结局
Ulcer Reduction Rate at 4 Weeks Post-ESD
时间窗: 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
次要结局
- Ulcer Reduction Rate at 8 Weeks Post-ESD(8 weeks after ESD procedure (±3 days))
- Ulcer Stage at 4 Weeks (Sakita Classification)(4 weeks after ESD procedure (±3 days))
- Complete Ulcer Healing Rate at 8 Weeks(8 weeks after ESD procedure (±3 days))
- Incidence of Delayed Bleeding(From 24 hours post-ESD up to 8 weeks)
- Change in Epigastric Pain Score(Baseline (Day 0), Day 7, Week 4, and Week 8)
- Change in Bloating Score(Baseline (Day 0), Day 7, Week 4, and Week 8)
- Change in Acid Reflux Score(Baseline (Day 0), Day 7, Week 4, and Week 8)
- Change in Quality of Life Score(Baseline (Day 0), Week 4, and Week 8)
- Rate of Rehospitalization Due to ESD-Related Complications(From Day 0 through Week 8)
- Need for Endoscopic Hemostatic Intervention(From Day 0 through Week 8)
- Incidence of Adverse Events(From Day 0 through Week 8)
- Medication Compliance Rate(Throughout 8-week treatment period)
研究者
Zhaofeng Chen
Clinical Professor
LanZhou University