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

Not Applicable

• Conditions: Intraductal papillary mucinous neoplasm; IPMN; D000077779

• Registration Number: JPRN-jRCTs051230154
• Lead Sponsor: Shinichi Yachida

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-12
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified