Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058695) titled 'Research on the diagnosis of pancreatic and biliary tract diseases based on acetone concentrations in duodenal fluid' on Aug. 13.
Study Type:
Observational
Primary Sponsor:
Institute - Hokkaido University
Condition:
Condition - Pancreaticobiliary diseases
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the diagnostic ability of acetone concentrations in duodenal fluid for distinguishing pancreaticobiliary malignant diseases from benign diseases
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Individuals with elevated serum liver and biliary enzymes, elevated serum tumor markers (CA19-9, CEA, DUPAN-2, Span-1), and abnormalities in the pancreas or biliary tract as revealed by imaging tests (abdominal ultrasound, CT, MRI, PET-CT, EUS)
2) Individuals aged 18 years or older
3) Individuals who have received adequate explanation regarding participation in the study, have fully understood the details, and have provided written informed consent based on their own free will or that of their legal representative or proxy.
Key exclusion criteria - 1) Individuals who cannot undergo oral or nasal endoscopy.
2) Individuals who are deemed unsuitable as research subjects by the attending physician.
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 30 Day
Date of IRB - 2025 Year 05 Month 08 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066880
Disclaimer: Curated by HT Syndication.
