Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing: A Randomized Controlled Trial
NCT ID: NCT07312370
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2026-01-20
2026-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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)
Esomeprazole (Intravenous)
Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
Esomeprazole (Oral)
Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
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).
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.
Esomeprazole Alone (Control Group)
* Days 1-3: Esomeprazole 40mg intravenously every 12 hours
* Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)
Esomeprazole (Intravenous)
Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
Esomeprazole (Oral)
Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
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.
Interventions
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Esomeprazole (Intravenous)
Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)
Esomeprazole (Oral)
Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)
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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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LanZhou University
OTHER
Responsible Party
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Zhaofeng Chen
Clinical Professor
Locations
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Countries
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Central Contacts
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Facility Contacts
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Qiangqiang Tian
Role: primary
Role: backup
References
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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.
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.
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. doi: 10.1055/a-1811-7025. Epub 2022 May 6.
Other Identifiers
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LDYYczf2025121701
Identifier Type: -
Identifier Source: org_study_id