KCT0006850尚未招募未知
The Effect of K-CAB (tegoprazan) for Prevention of Artificial Ulcers bleeding after Endoscopic Submucosal Dissection: A Multicenter, Randomized, Open, Active-controlled Study
Kyung Hee University Hospital0 个研究点目标入组 286 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
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
- 19?(Year) 至 74?(Year)（—）
- 性别
- All
入选标准
- •1) Those who are between 20 and 75 years of age as of the date of obtaining written consent
- •2) Patients who have been diagnosed with gastric adenoma or early gastric cancer and need to undergo endoscopic submucosal dissection (ESD) for treatment.
- •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) A person who can understand and follow the instructions and can participate in the entire clinical trial period
- •5) Those who voluntarily decided to participate and gave written consent to the clinical trial subject consent form
- •6) Those who agree to use contraceptive methods (including medically impossible conditions) during the clinical trial period
排除标准
- •1) Those who have confirmed gastrointestinal bleeding or perforation in the upper gastrointestinal endoscopy performed during screening
- •2) Those who have undergone major surgery that may affect gastric acid secretion in the past.
- •3) Those with Zollinger-Ellison syndrome or other gastric acid secretion disorders or a history
- •4) Those who cannot follow-up upper gastrointestinal endoscopy
- •5) Those who have hypersensitivity reactions to tegoprazan or proton pump inhibitors or benzimidazoles and have a history of such reactions
- •6) Those who are taking atazanavir, nelfinavir, or rilpivirine-containing preparations
- •7) Pregnant or lactating women
- •8) Uncontrolled cardiopulmonary disease, renal disease, liver disease, endocrine disease, cranial nerve disease, etc.
- •9) When it is difficult to conduct appropriate research due to cognitive impairment, intellectual disability, mental illness, etc.
- •10) When taking PPI, H2 blocker, or prokinetics within 2 weeks before endoscopic submucosal dissection
- •11) In case of taking antiplatelet drugs or anticoagulants within 1 week before endoscopic submucosal dissection
- •12) In case of continuous use of corticosteroids, NSAIDs, aspirin and other antiplatelet drugs, anticoagulants and contraindicated drugs during the clinical trial period
- •13) When AST, ALT, ALP, GGT, and total bilirubin levels are more than twice the upper limit reference value (UNL), or creatinine levels are more than twice the upper limit reference value
- •14) Those with a history of malignant tumors within the past 5 years
- •15) In case of thrombocytopenia or dysfunction (=20,000/µL)
- •16) Those who participated in other clinical trials within 12 weeks of Visit 2 (random assignment date)
- •17) Patients with a history of alcohol abuse
- •18) Except the above, those who have clinically significant findings that the investigator judges to be inappropriate for this study
研究者
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