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

JRCT ID: jRCTs051200116

Registered date:22/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 20/08/2021
• Target sample size: 120
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Sensitivity, specificity, and predictive values for detecting pancreatic cancer

Secondary Outcome

Volume 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 maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Yachida Shinichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)