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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole + Sucralfate (Intervention Group) | Experimental |
|
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| Esomeprazole Alone (Control Group) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole (Intravenous) | Drug | Esomeprazole 40mg intravenously every 12 hours for 3 days (Days 1-3 post-ESD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer Reduction Rate at 8 Weeks Post-ESD | Same calculation method as primary outcome, assessed at 8 weeks | 8 weeks after ESD procedure (±3 days) |
| Ulcer Stage at 4 Weeks (Sakita Classification) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiangqiang Tian | Contact | 86+15009460497 | tianqq2023@lzu.edu.cn | |
| Zhaofeng Chen | Contact | 86+15009460497 | zhfchen@lzu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24010587 | Background | 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. | |
| 22533757 | Background |
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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.
|
| Esomeprazole (Oral) | Drug | Esomeprazole 40mg orally once daily, taken before breakfast, for 8 weeks (Days 4-56) |
|
|
| 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. |
|
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.
| 4 weeks after ESD procedure (±3 days) |
| 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 | 8 weeks after ESD procedure (±3 days) |
| 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. | From 24 hours post-ESD up to 8 weeks |
| 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. | Baseline (Day 0), Day 7, Week 4, and Week 8 |
| 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. | Baseline (Day 0), Day 7, Week 4, and Week 8 |
| 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. | Baseline (Day 0), Day 7, Week 4, and Week 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. | Baseline (Day 0), Week 4, and Week 8 |
| 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 | From Day 0 through Week 8 |
| 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 | From Day 0 through Week 8 |
| 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 | From Day 0 through Week 8 |
| 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. | Throughout 8-week treatment period |
| 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. |
| 35523224 | 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. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010438 | Peptic Ulcer Hemorrhage |
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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