Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058499) titled 'Comparative study of endoscopic ultrasound-guided treatment and balloon-enteroscopy assisted endoscopic retrograde cholangiopancreatography approach for the treatment of large bile duct stone removal in surgically altered anatomy' on July 17.
Study Type:
Observational
Primary Sponsor:
Institute - Oita University
Condition:
Condition - large bile duct stone in patients with surgical altered anatomy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Comparison of complete stone removal rate of endoscopic ultrasound-guided treatment and balloon enteroscopy assisted endoscopic retrograde cholangiopancreatography for large bile duct stone in patients with surgical altered anatomy
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - From January 2016 to February 2025, patients and endoscopic procedures for bile duct stones in surgical altered anatomy (SAA) treated with either EUS-T or BE-ERCP.
Bile duct stone 12mm or more in diameter
Key exclusion criteria - In patients who underwent EUS-T sessions following failed BE-ERCP sessions, or BE-ERCP sessions following failed EUS-T sessions, each EUS-T and BE-ERCP both the failed and subsequent alternative sessions was analyzed and compared separately as an individual session series if there was no change in the size and number of target stones. Cases treated alternately with EUS-T and BE-ERCP repeatedly (e.g., first treatment with EUS-T, second with BE-ERCP, third with EUS-T), those treated using the rendezvous technique, those who underwent on going treatment, cases without adequate datasets were excluded.
Target Size - 130
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 27 Day
Date of IRB - 2025 Year 06 Month 27 Day
Anticipated trial start date - 2025 Year 07 Month 17 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=R000066882
Disclaimer: Curated by HT Syndication.