NIPH Clinical Trials Search

JRCT ID: jRCTs051200116

Registered date:22/01/2021

Usefulness of a screening test for pancreatic cancer by detection of gene mutations in duodenal juice collected using secretin and a specially-made catheter following gastrointestinal endoscopy in high-risk individuals

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedpancreatic cancer
Date of first enrollment20/08/2021
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)Synthetic secretin 0.2 mcg/kg is injected intravenously prior to gastrointestinal endoscopy over 1 minute and a specially-made catheter is used to collect duodenal juice following conventional gastrointestinal endoscopy.


Primary OutcomeSensitivity, specificity, and predictive values for detecting pancreatic cancer
Secondary OutcomeVolume of the collected duodenal juice Adverse events within next day after administration of the study drug

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Patient-provided informed consent and over 20 years old 2) Patients in high-risk groups for pancreatic cancer (Onomichi City Cohort, Matsue City Cohort, Kokugan Cohort, Osaka National Cancer Center Cohort, Wakayama Medical University Cohort, Aichi Cancer Center Cohort) on whom EUS,EUS-FNA, or ERCP will be performed 3) Persons who have given their written consent to participate in this research
Exclude criteria1) Patients with hypersensitivity to secretin or other ingredients (excipients: cysteine hydrochloride and mannitol) 2) Patients in remission from acute pancreatitis or acute exacerbations of chronic pancreatitis within 2 weeks of the start of administration of the study drug 3) Patients who don't discontinue anticholinergic drugs at least 5 half-lives prior to the start of administration of the study drug 4) Pregnant or lactating women 5) Patients who received other research drugs or investigational drugs within 3 months of the start of administration of the study drug 6) Patients who are hard to observe a duodenal papilla with an endoscope 7) Patients whom the doctor in charge judges inappropriate

Related Information


Public contact
Name Hidenori Tanaka
Address 2-2 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3360
Affiliation Graduate School of Medicine, Osaka University
Scientific contact
Name Shinichi Yachida
Address 2-15 Yamadaoka, Suita, Osaka Osaka Japan 565-0871
Telephone +81-6-6879-5111
Affiliation Osaka University Hospital