Study on the diagnosis of intraductal papillary mucinous neoplasm (IPMN) using duodenal lavage fluid collected by esophagogastroduodenoscopy with a synthetic human secretin and a specific catheter for diagnosing IPMN grade

Shinichi Yachida0 个研究点目标入组 250 人开始时间: 2024年1月12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 18 years of age or older at the time of consent
•2) Patients with PMN (or suspected IPMN based on diagnostic imaging, etc.) and registrants who do not have IPMN, pancreatic cancer, or cancer in other organs at the time of examination and are scheduled for endoscopic examination
•3) Written consent for participation 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) Individuals who have been diagnosed (or suspected) with conventional pancreatic cancer at the point of enrollment.
•8) Other subjects who are deemed inappropriate by the principal investigator

发起方

Shinichi Yachida