Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059760) titled 'Prospective evaluation study of diagnostic yield for biliary disease using modified tetra-bite-on-bite biopsy' on Dec. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Osaka Medical and Pharmaceutical University
Condition:
Condition - Biliary disease
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Diagnostic accuracy of modified tetra-bite-on-bite technique
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Biopsy using modified tetra-bite-on-bite technique
Interventions/Control_2 - Historical control
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Complicating biliary disease
2. age from 18 to 99
3. Obtaining informed consent
Key exclusion criteria - 1. Bleeding tendency, pregnancy
2. Surgical altered anatomy excluding Bil-1
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 27 Day
Date of IRB - 2025 Year 11 Month 13 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2030 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068337
Disclaimer: Curated by HT Syndication.
