JPRN-jRCTs061230040招募中2 期
An exploratory study to evaluate the detection ability of photodynamic endoscopic imaging for differentiated gastric cancer and gastric adenoma in patients with current or past Helicobacter.pylori infection: a multicenter in terventional study
Isomoto Hajime0 个研究点目标入组 80 人开始时间: 2023年7月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients scheduled for endoscopic resection of differentiated gastric cancer or gastric adenoma in the stomach after HP infection or eradication
- •2) Patients of over 18 years at the time of consent
- •3) Patients with ECOG Performance Status 0 or 1
- •4) Patients with preserved function of major organs such as heart, lungs, liver, and kidney. In particul
- •ar, the liver, kidneys, and blood coagulation capacity must meet the following criteria based on blood tests at screening.
- •-Liver: bilirubin < upper limit of normal range (ULN) * 1.5, ALT < ULN * 3, AST < ULN * 3; bilirubin < ULN * 3 if Gilbert's syndrome is suspected
- •-Kidney: creatinine 45ml/min
- •-Blood coagulability: PT INR and APTT values judged acceptable by the study investigator to undergo endoscopic examination.
- •5) Females of reproductive potential and males who are willing to use a highly effective contracepti
- •ve method (Pearl index <1) during the study period.
- •(6) Patients who have given free and voluntary written consent to the study
排除标准
- •1) Patients with a history of gastric surgery
- •2) Patients scheduled on endoscopic resection for recurrence after endoscopic treatment
- •3) Patients with active cancer of other organs
- •4) Patients with hypersensitivity to porphyrin analogues
- •5) Patients with a history of photosensitivity
- •6) Patients with serious infections
- •7) Patients with contraindications to gastrointestinal endoscopy
- •8) Pregnant or lactating women, or women of childbearing potential
- •9) Other patients deemed ineligible by the principal investigator or subinvestigator
研究者
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