Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

Official title

Intravenous Esomeprazole Combined With Sucralfate Suspension for Ulcer Healing and Complication Prevention After Gastric Endoscopic Submucosal Dissection: A Prospective, Randomized, Controlled Trial

Overview

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

• Drug Esomeprazole (Intravenous)
  Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
• Drug Esomeprazole (Oral)
  Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
• Drug Sucralfate 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).
• Procedure Gastric 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.

Primary outcome measures

• Ulcer Reduction Rate at 4 Weeks Post-ESD [Time frame: 4 weeks after ESD procedure (±3 days)]

Secondary outcome measures (12)

• Ulcer Reduction Rate at 8 Weeks Post-ESD [Time frame: 8 weeks after ESD procedure (±3 days)]
• Ulcer Stage at 4 Weeks (Sakita Classification) [Time frame: 4 weeks after ESD procedure (±3 days)]
• Complete Ulcer Healing Rate at 8 Weeks [Time frame: 8 weeks after ESD procedure (±3 days)]
• Incidence of Delayed Bleeding [Time frame: From 24 hours post-ESD up to 8 weeks]
• Change in Epigastric Pain Score [Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8]
• Change in Bloating Score [Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8]
• Change in Acid Reflux Score [Time frame: Baseline (Day 0), Day 7, Week 4, and Week 8]
• Change in Quality of Life Score [Time frame: Baseline (Day 0), Week 4, and Week 8]
• Rate of Rehospitalization Due to ESD-Related Complications [Time frame: From Day 0 through Week 8]
• Need for Endoscopic Hemostatic Intervention [Time frame: From Day 0 through Week 8]
• Incidence of Adverse Events [Time frame: From Day 0 through Week 8]
• Medication Compliance Rate [Time frame: Throughout 8-week treatment period]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Hospital of Lanzhou University — Lanzhou

Publications

• Takeuchi T, Ota K, Harada S, Edogawa S, Kojima Y, Tokioka S, Umegaki E, Higuchi K. The postoperative bleeding rate and its risk factors in patients on antithrombotic therapy who undergo gastric endoscopic submucosal dissection. BMC Gastroenterol. 2013 Sep 6;13:136. doi: 10.1186/1471-230X-13-136. PMID 24010587
• Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x. PMID 22533757
• Pimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. PMID 35523224

Identifiers

NCT: NCT07312370 · LDYYczf2025121701

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗