sefulness 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
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCTs051200116
- Lead Sponsor
- Yachida Shinichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1) 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
1) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity, specificity, and predictive values for detecting pancreatic cancer
- Secondary Outcome Measures
Name Time Method Volume of the collected duodenal juice<br>Adverse events within next day after administration of the study drug