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NCT Number: NCT07312370

Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

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.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Gastric Dysplasia Gastric Neoplasms Gastric Ulcer Gastrointestinal Diseases Gastrointestinal Hemorrhage Gastrointestinal Neoplasms Hemorrhage Intestinal Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Peptic Ulcer Hemorrhage Peptic Ulcer With Haemorrhage Stomach Diseases Stomach Neoplasms Stomach Ulcer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole (Intravenous)

Drug

Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD)

Other names: Esomeprazole Sodium

Esomeprazole (Oral)

Drug

Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56)

Other names: Esomeprazole Magnesium

Sucralfate Suspension

Drug

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)

Procedure

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 outcomes

  1. Ulcer Reduction Rate at 4 Weeks Post-ESD

    Time frame: 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 outcomes

  1. Ulcer Reduction Rate at 8 Weeks Post-ESD

    Time frame: 8 weeks after ESD procedure (±3 days)

    Same calculation method as primary outcome, assessed at 8 weeks

  2. Ulcer Stage at 4 Weeks (Sakita Classification)

    Time frame: 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.

  3. Complete Ulcer Healing Rate at 8 Weeks

    Time frame: 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

  4. Incidence of Delayed Bleeding

    Time frame: 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.

  5. Change in Epigastric Pain Score

    Time frame: 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.

  6. Change in Bloating Score

    Time frame: 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.

  7. Change in Acid Reflux Score

    Time frame: 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.

  8. Change in Quality of Life Score

    Time frame: 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.

  9. Rate of Rehospitalization Due to ESD-Related Complications

    Time frame: 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

  10. Need for Endoscopic Hemostatic Intervention

    Time frame: 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

  11. Incidence of Adverse Events

    Time frame: 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

  12. Medication Compliance Rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiangqiang Tian

CONTACT

[email protected]

86+15009460497

Zhaofeng Chen

CONTACT

[email protected]

86+15009460497

Sponsors and collaborators

Lead sponsor

LanZhou University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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