Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062694) titled 'A Phase I Study of a Novel Linkage Technique for Multisegmental Biliary Drainage Through a Single EUS-HGS or EUS-HDS Fistula in Unresectable Malignant Hilar Biliary Obstruction' on Aug. 26.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Aichi Cancer Center
Condition:
Condition - Unresectable malignant hilar biliary obstruction
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the safety of a novel linkage biliary drainage technique connecting two ipsilateral intrahepatic bile duct branches through a single EUS-HGS or EUS-HDS fistula in patients with unresectable malignant hilar biliary obstruction.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - As biliary drainage for malignant hilar biliary obstruction, EUS-guided biliary drainage of two ipsilateral intrahepatic bile duct branches (e.g., B2 and B3 or B6 and B7) is performed in a single session through a single fistula using EUS-HGS or EUS-HDS.
Eligibility:
Age-lower limit - 20
years-old
=1.5
APTT >1.5 times the upper limit of normal
3.Patients with obvious disseminated tumor nodules or other findings on imaging that make safe puncture difficult.
4.Patients who are considered unsuitable for participation in this study by the investigator.
Target Size - 9
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 05 Month 12 Day
Date of IRB - 2026 Year 08 Month 10 Day
Anticipated trial start date - 2026 Year 08 Month 26 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071782
Disclaimer: Curated by HT Syndication.
