NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051230169

Registered date:25/01/2024

Development of a diagnostic method for pancreatic cancer by esophagogastroduodenoscopy using a synthetic human secretin preparation and a special catheter

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPersons at high risk of pancreatic cancer
Date of first enrollment25/01/2024
Target sample size300
Countries of recruitmentNA,Japan
Study typeInterventional
Intervention(s)1) Synthetic human secretin (ChiRhoStim secretin) 2) Duodenal fluid collection device (tentative) (Manufacturer: Fuji Systems, Inc.)

Outcome(s)

Primary OutcomeSensitivity and specificity of this test method for early diagnosis (pancreatic cancer indicated for surgery) in the high-risk group for pancreatic cancer, and positive and negative predictive values
Secondary Outcome1) Quantification of duodenal lavage collection fluid 2) Comparative evaluation of diagnostic performance between this test and established imaging modalities such as abdominal ultrasonography and endoscopic ultrasonography (EUS). 3) The assessment of whether pancreatic cancer will occur by the conclusion of the enrollment period (December 2025).

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Yachida Shinichi
Address 2-15 Yamadaoka, Suita, Osaka 565-0871 Osaka Japan 565-0872
Telephone +81-6-6879-5111
E-mail syachida@cgi.med.osaka-u.ac.jp
Affiliation Osaka University Hospital
Scientific contact
Name Yachida Shinich
Address 2-15 Yamadaoka, Suita, Osaka 565-0871 Osaka Japan 565-0872
Telephone +81-6-6879-5111
E-mail syachida@cgi.med.osaka-u.ac.jp
Affiliation Osaka University Hospital