Investigation of the usefulness of a screening test for pancreatic cancer based on highly sensitive detection of gene mutations in duodenal juice collected using synthetic human secretin and a specially made catheter following conventional esophagogastroduodenoscopy in high-risk individuals

Shinich Yachida0 个研究点目标入组 300 人开始时间: 2024年1月25日最近更新: 2024年4月23日

适应症

试验速览

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•1) Men and women aged 18 years or older at the time of consent acquisition
•2) Subjects diagnosed as high-risk in a prospective cohort (Onomichi Cohort, Matsue Cohort, National Cancer Cohort, Osaka International Cancer Center Cohort, Tottori University Cohort, Wakayama Medical University Cohort, Aichi Cancer Center Cohort) and undergo EUS (endoscopic ultrasound) examination.
•3) Written consent to participate in this study has been obtained from the subject

•1) Subjects with hypersensitivity to secretin or other ingredients (excipients: cysteine hydrochloride and mannitol)
•2) Subjects within two weeks of remission from acute exacerbation of acute pancreatitis or chronic pancreatitis
•3) Subjects who cannot take anticholinergic drugs for five half-lives before endoscopy
•4) Pregnant or lactating women
•5) Subjects who have received other study or investigational drugs within three months prior to the start of study drug administration
•6) Subjects who are difficult to observe the duodenal papilla (e.g., postoperative patients)
•7) Patients with suspected or diagnosed conventional pancreatic cancer or intraductal papillary mucinous tumor at registration
•8) Other Subjects who are deemed inappropriate by the principal investigator

发起方

Shinich Yachida