A study on the grading of intraductal papillary mucinous tumor (IPMN) by esophagogastroduodenoscopy using a synthetic human secretin preparation and a specialized catheter

JRCT ID: jRCTs051230154

Registered date:12/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intraductal papillary mucinous neoplasm
• Date of first enrollment: 12/01/2024
• Target sample size: 250
• Countries of recruitment: No,Japan
• Study type: Interventional

Intervention(s)

1) Synthetic human secretin (ChiRhoStim)
2) Duodenal fluid collection device (tentative) (Fuji Systems Co., Ltd.)

Outcome(s)

• Primary Outcome: Sensitivity and specificity of this test method for IPMN (Intraductal papillary mucinous neoplasm) grading

Secondary Outcome

Quantity of duodenal lavage fluid collected
Comparison of the diagnosis of IPMN malignancy by this test with that of diagnostic imaging and detailed examination

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and women 18 years of age or older at the time of consent
2) Patients with PMN (or suspected IPMN based on diagnostic imaging, etc.) and registrants who do not have IPMN, pancreatic cancer, or cancer in other organs at the time of examination and are scheduled for endoscopic examination
3) Written consent for participation 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) Individuals who have been diagnosed (or suspected) with conventional pancreatic cancer at the point of enrollment.
8) Other subjects who are deemed inappropriate by the principal investigator

Related Information

• Primary Sponsor: Shinichi Yachida
• Secondary Sponsor: Japan Agency for Medical Research and Development (AMED)
• Secondary ID(s): Nil known