Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

NCT07312370 | Not Yet Recruiting Phase 4

• 1 other identifier: LDYYczf2025121701
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Gastric Cancer; Gastric Dysplasia; Gastric Neoplasms; Peptic Ulcer With Haemorrhage; Gastric Ulcer

Keywords

Endoscopic Submucosal Dissection; Gastric Cancer; Ulcer Healing; Proton Pump Inhibitor; Post-ESD Ulcer; Early Gastric Neoplasm

Outcome Measures

Primary Outcomes (1)

• Ulcer Reduction Rate at 4 Weeks Post-ESD

  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

  4 weeks after ESD procedure (±3 days)

Secondary Outcomes (12)

• 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

Study Arms (2)

Esomeprazole + Sucralfate (Intervention Group)

EXPERIMENTAL

* 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)

Drug: Esomeprazole (Intravenous); Drug: Esomeprazole (Oral); Drug: Sucralfate Suspension; Procedure: Gastric Endoscopic Submucosal Dissection (ESD)

Esomeprazole Alone (Control Group)

ACTIVE COMPARATOR

* Days 1-3: Esomeprazole 40mg intravenously every 12 hours * Days 4-56: Esomeprazole 40mg orally once daily (before breakfast)

Drug: Esomeprazole (Intravenous); Drug: Esomeprazole (Oral); Procedure: Gastric Endoscopic Submucosal Dissection (ESD)

Interventions

Esomeprazole (Intravenous) DRUG

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

Also known as: Esomeprazole Sodium

Esomeprazole + Sucralfate (Intervention Group); Esomeprazole Alone (Control Group)

Esomeprazole (Oral) DRUG

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

Also known as: Esomeprazole Magnesium

Esomeprazole + Sucralfate (Intervention Group); Esomeprazole Alone (Control Group)

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).

Esomeprazole + Sucralfate (Intervention Group)

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.

Esomeprazole + Sucralfate (Intervention Group); Esomeprazole Alone (Control Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35523224 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Peptic Ulcer Hemorrhage; Stomach Ulcer

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastrointestinal Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Qiangqiang Tian

CONTACT

86+15009460497; tianqq2023@lzu.edu.cn

Zhaofeng Chen

CONTACT

86+15009460497; zhfchen@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)