Development of a screening test for pancreatic cancer by gastrointestinal endoscopy using synthetic human secretin and a specially-made catheter

JRCT ID: jRCTs051200117

Registered date:22/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: 1. Pancreatic cancer or suspected pancreatic cancer 2. Neither pancreatic cancer nor other cancers
• Date of first enrollment: 27/07/2021
• Target sample size: 150
• 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 and specificity of pancreatic cancer diagnosis

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 with pancreatic cancer or suspected of pancreatic cancer (N=100) and Participants without pancreatic cancer or other cancers (N=50) (Planned endoscopy)
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 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)