KCT0005470尚未招募未知
The Effect of K-CAB (tegoprazan) for Treating Endoscopic Submucosal Dissection Induced Artificial Ulcers : A Multicenter, Randomized, Active controlled Study
Koera University Guro Hospital0 个研究点目标入组 160 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Those whose age is 20 to 75 years old as of the date of obtaining written consent
- •2) Patients diagnosed with gastric adenoma or early gastric cancer and underwent endoscopic submucosal dissection (ESD) for treatment purposes
- •3) In any of the following cases
- •-Gastric adenoma
- •-Undifferentiated early gastric cancer of less than 2.0 cm, limited to the mucous membrane and without ulcers
- •-Differentiated early gastric cancer limited to the mucous membrane regardless of the size of the lesion and without ulcers
- •-Differentiated early gastric cancer of less than 3.0 cm limited to the mucous membrane and accompanied by ulcers
- •-Differentiated early gastric cancer less than 3.0 cm invading the submucosal layer less than 500 µm and not accompanied by ulcers
- •4) When the maximum diameter of the specimen of the removed iatrogenic ulcer is less than 4 cm
- •5) Those who understand and follow instructions and can participate in the entire clinical trial period
- •6) A person who voluntarily decides to participate and agrees in writing to the consent of the subject
- •7) Those who agreed to use contraceptive methods (including medically impossibility of pregnancy) during the clinical trial period
排除标准
- •1) If overt bleeding or perforation occurs within 48 hours after endoscopic submucosal dissection (ESD) (hematmesis, bloody stool, black stool symptoms, suspected perforation on radiography, etc.)
- •2) In case of esophageal stenosis, ulcer stenosis, pyloric stenosis, peptic ulcer and perforation on upper gastrointestinal endoscopy
- •3) If there is a history of previous upper gastrointestinal surgical resection
- •4) Those who are unable to perform follow-up upper gastrointestinal endoscopy
- •5) Those who have a history of hypersensitivity reactions to components of tegoprazan or proton pump inhibitors or benzimidazoles
- •6) Those who are administering atazanavir, nelpinavir, or drug containing rilpivirine, terfenadine, cisapride, pimozide, astemizole
- •7) pregnant or lactating women
- •8) Uncontrolled cardiopulmonary disease, kidney disease, liver disease, endocrine disease (especially in patients with severe diabetes), cranial nerve disease, etc.
- •9) When it is difficult to conduct appropriate research due to cognitive or intellectual disability
- •10) If you are taking antipsychotics, antidepressants, or anti-anxiety drugs
- •11) When taking PPI, H2 blocker, or prokinetics within 2 weeks before endoscopic submucosal dissection (ESD)
- •12) If you need to continue taking steroids, NSAIDs, aspirin and other antiplatelet drugs, anticoagulants, etc. during the clinical trial period
- •13) When AST, ALT, ALP, GGT, total bilirubin levels are more than twice the upper limit reference value (or BUN, creatinine levels are more than 1.5 times the upper limit reference value)
研究者
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