None listed
Conditions
Interventions
Drug : This study is a prospective, randomized, active drug control clinical trial. Clinical trial subjects who agree to participate in the clinical trial are assigned a screening number in the order
Sponsors
Soon Chun Hyang University Hospital Cheonan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults whose age is 19 to 75 years of age as of the date of acquisition of written consent 2. Patients diagnosed with ????? or early gastric cancer and underwent endoscopic submucosal dissection (ESD) for treatment purposes 3. ????? Any of the following - gastric adenoma - undifferentiated early gastric cancer of 2.0 cm or less confined to the mucous membrane and not accompanied by ulcers - differentiated early gastric cancer confined to the mucous membrane and not accompanied by ulcers, regardless of the size of the lesion - differentiated early gastric cancer of 3.0 cm or less confined to the mucous membrane and accompanied by ulcers - Differentiated early gastric cancer of 3.0 cm or less invading submucosal layer 500 µm or less and not accompanied by ulcers 4. If the longest diameter of the tissue resected through endoscopic submucosal dissection (ESD) is less than 4 cm 5. A person who understands and follows instructions and can participate in the pre-clinical period 6. A person who voluntarily decides to participate and agrees in writing to the consent of the subject of the clinical trial 7. A person who has consented to the use of medically reasonable contraception* (including medically impregnable conditions) during the clinical trial *Medically valid contraception: hormonal transplants, IUDs, fertilizer barrier methods, condoms, abstinence, etc
Exclusion criteria
Exclusion criteria: 1. If overt bleeding or perforation occurs within 48 hours after endoscopic submucosal dissection (ESD), such as hemoptysis, bloody stool, black stool symptoms, suspected perforation on radiography, etc 2. In the case of esophageal stenosis, ulcer stenosis, pylori stenosis, peptic ulcer, and perforation on the upper gastrointestinal tract endoscopy 3. If you take PPI, H2 blocker, or prokinetics within 2 weeks before the endoscopic submucosal dissection (ESD) 4. ????? When continuous use of steroids, NSAIDs, aspirin and other antiplatelet drugs, anticoagulants, etc. is required during the clinical trial 5. ????? If you have a previous history of upper gastrointestinal surgical resection 6. A person who is unable to follow up upper gastrointestinal endoscopy 7. ?? A person who has a history of hypersensitivity to zastafrazan or PPI components or benzimidazoles 8. Those who are hypersensitivity to penicillin antibiotics or macrolide antibiotics 9. Those who are administering atazanavir, nelfinavir or lilfibirin-containing agents, terphenadin, cisafrid, fimozid, and astemisol 10. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption 11. ?? a person with clinically significant liver and kidney disease 12. People taking antipsychotic drugs, antidepressants, and anti-anxiety drugs 13. A person with a history of ?????? myocardial infarction and its history 14. a pregnant woman or nursing woman 15. As a result of clinical laboratory testing performed at the time of screening, a person showing the following figures - >3 times the upper limit of the normal range of AST, ALT, ALP, and total bilirubin in the blood - eGFR (estimated Glomerular Filtration Rate) < 30 mL/min/1.73m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4 weeks after clinical trial drug administration, upper gastrointestinal endoscopy healing rate (referring to the Sakita-Miwa classification method, all white-covered ulcers are gone, and mucosal defects are healed (S1 or S2 stage) | — |
Secondary
| Measure | Time frame |
|---|---|
| After administration of clinical trial drugs for up to 8 weeks, the cumulative healing rate by upper gastrointestinal endoscopy (referring to the Sakita-Miwa classification method in which all white-covered ulcers have disappeared and mucosal defects have healed (S1 or S2 stage);Healing rates at 4 and 8 weeks depending on H. pylori infection;Change in ulcer size after clinical trial drug administration versus baseline;In the upper gastrointestinal endoscopy at 4 weeks and 8 weeks of clinical trial drug administration, the ulcer scar observed visually is evaluated by the following three criteria: (a) Flater scar, (b) Intermediate scar, and (c) Nodular scar;Delayed incidence of bleeding = (number of clinical trial subjects with bleeding within 4 weeks/number of clinical trial subjects who underwent upper gastrointestinal endoscopy after administration of clinical trial drugs) × 100;Evaluation of discomfort/pain VAS for 10 days and 4 weeks from the day after ESD(endoscopic submucosal dissection) procedure;Check safety evaluation variables (gastrin test, CRP test, vital signs, physical examination, adverse event) | — |
Countries
Korea, Republic of
Contacts
Public ContactYEON JUNG YOUN
Chungnam National University Hospital
Outcome results
None listed