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

JRCT ID: jRCTs051230169

Registered date:25/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Persons at high risk of pancreatic cancer
• Date of first enrollment: 25/01/2024
• Target sample size: 300
• Countries of recruitment: NA,Japan
• Study type: Interventional

Intervention(s)

1) Synthetic human secretin (ChiRhoStim secretin)
2) Duodenal fluid collection device (tentative) (Manufacturer: Fuji Systems, Inc.)

Outcome(s)

• Primary Outcome: Sensitivity 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 Outcome

1) 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Shinich Yachida
• Secondary Sponsor: Japan Agency for Medical Research and Development (AMED)