Intraductal papillary mucinous neoplasm IPMN
Conditions
Interventions
1) Synthetic human secretin (ChiRhoStim)
2) Duodenal fluid collection device (tentative) (Fuji Systems Co., Ltd.)
Sponsors
Shinichi Yachida
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of this test method for IPMN (Intraductal papillary mucinous neoplasm) grading | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantity of duodenal lavage fluid collected Comparison of the diagnosis of IPMN malignancy by this test with that of diagnostic imaging and detailed examination | — |
Countries
Japan, No
Contacts
Public ContactShinichi Yachida
Osaka University Hospital
Outcome results
None listed