AzTrials
AzTrials

Early Gastric CancerPhase 4NCT07312370

Esomeprazole Plus Sucralfate for Post-ESD Ulcer Healing

A Phase 4 study testing Esomeprazole (Intravenous), Esomeprazole (Oral) and Sucralfate Suspension in people with Early Gastric Cancer and Gastric Dysplasia, run by LanZhou University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Esomeprazole (Intravenous), Esomeprazole (Oral) and Sucralfate Suspension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
20 Apr 2026to 30 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • ECOG performance status 0-1
  • Able to comply with follow-up visits and endoscopic examinations
  • Voluntary participation with written informed consent

Who cannot join

  • 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%)
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiangqiang Tian contact

86+15009460497

tianqq2023@lzu.edu.cn

Zhaofeng Chen contact

86+15009460497

zhfchen@lzu.edu.cn

China1 site

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Qiangqiang Tian, 86+15009460497, tianqq2023@lzu.edu.cn

    tianqq2023@lzu.edu.cn

Other trials in China

About this study

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

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.

Read more

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.

Being tested
Esomeprazole (Intravenous), Esomeprazole (Oral), Sucralfate Suspension, Gastric Endoscopic Submucosal Dissection (ESD)
Keywords
Endoscopic Submucosal Dissection, Gastric Cancer, Ulcer Healing, Proton Pump Inhibitor, Post-ESD Ulcer, Early Gastric Neoplasm
Medical subject headings
Stomach Neoplasms, Peptic Ulcer Hemorrhage, Stomach Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esomeprazole (Intravenous)Drug

    Also called Esomeprazole Sodium

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

  • Esomeprazole (Oral)Drug

    Also called Esomeprazole Magnesium

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

  • Sucralfate SuspensionDrug

    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 or surgery

    Standardized gastric ESD procedure including lesion marking, submucosal injection, circumferential incision, submucosal dissection, and complete coagulation of all visible vessels at the ulcer base.

Study groups in NCT07312370
Study groupRoleWhat they receive
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)
Receives: 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)
Receives: Drug: Esomeprazole (Intravenous); Drug: Esomeprazole (Oral); Procedure: Gastric Endoscopic Submucosal Dissection (ESD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks after ESD procedure (±3 days)

Secondary outcomes (12)

  1. Ulcer Reduction Rate at 8 Weeks Post-ESD

    Same calculation method as primary outcome, assessed at 8 weeks

    Measured: 8 weeks after ESD procedure (±3 days)

  2. Ulcer Stage at 4 Weeks (Sakita Classification)

    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.

    Measured: 4 weeks after ESD procedure (±3 days)

  3. Complete Ulcer Healing Rate at 8 Weeks

    Proportion of patients achieving complete ulcer healing defined as scar stage (S1 or S2) on Sakita classification at 8 weeks post-ESD

    Measured: 8 weeks after ESD procedure (±3 days)

  4. Incidence of Delayed Bleeding

    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.

    Measured: From 24 hours post-ESD up to 8 weeks

  5. Change in Epigastric Pain Score

    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.

    Measured: Baseline (Day 0), Day 7, Week 4, and Week 8

  6. Change in Bloating Score

    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.

    Measured: Baseline (Day 0), Day 7, Week 4, and Week 8

  7. Change in Acid Reflux Score

    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.

    Measured: Baseline (Day 0), Day 7, Week 4, and Week 8

  8. Change in Quality of Life Score

    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.

    Measured: Baseline (Day 0), Week 4, and Week 8

  9. Rate of Rehospitalization Due to ESD-Related Complications

    Proportion of patients requiring rehospitalization due to post-ESD complications including delayed bleeding, severe pain, or other ESD-related adverse events

    Measured: From Day 0 through Week 8

  10. Need for Endoscopic Hemostatic Intervention

    Proportion of patients requiring emergency or urgent endoscopic hemostatic procedures (such as hemoclipping, coagulation, or injection therapy) for post-ESD bleeding

    Measured: From Day 0 through Week 8

  11. Incidence of Adverse Events

    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

    Measured: From Day 0 through Week 8

  12. Medication Compliance Rate

    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.

    Measured: Throughout 8-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312370
Sponsor's protocol ID
LDYYczf2025121701
Status last verified
Mar 2026
First submitted
17 Dec 2025
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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. doi: 10.1055/a-1811-7025. Epub 2022 May 6.

    PubMed 35523224

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esomeprazole (Intravenous), Esomeprazole (Oral) and Sucralfate Suspension in people with Early Gastric Cancer and Gastric Dysplasia, run by LanZhou University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qiangqiang Tian (86+15009460497, tianqq2023@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ulcer Reduction Rate at 4 Weeks Post-ESD (time frame: 4 weeks after ESD procedure (±3 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07312370, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in