Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061426) titled 'Efficacy and safety of EUS-guided hepaticoduodenostomy for unresectable malignant hilar biliary obstruction: A multicenter retrospective study using propensity score matching' on May 1.
Study Type:
Observational
Primary Sponsor:
Institute - National Cancer Center Japan
Condition:
Condition - Unresectable malignant hilar biliary obstruction
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To retrospectively investigate the technical and clinical success, safety profile, time to recurrent biliary obstruction (TRBO), and re-intervention success of EUS-HDS in patients with unresectable MHBO.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Cohort 1(Single-arm analysis):
Patients who underwent EUS-HDS for unresectable malignant hilar biliary obstruction (MHBO) between January 2015 and April 2026.
Cohort 2 (Comparative analysis):
Patients who underwent either EUS-HDS or EUS-HGS for unresectable MHBO between January 2015 and April 2026.
Key exclusion criteria - General exclusion criteria (for both cohorts):
1) Benign biliary strictures.
2) Malignant biliary strictures resulting from postoperative anastomotic recurrence.
3) Bismuth type I malignant hilar biliary obstruction (MHBO).
Specific exclusion criteria for Cohort 2 (Comparative analysis):
1) Cases involving EUS-guided biliary drainage (EUS-BD) with bridging stenting.
2) Cases in which both EUS-HDS and EUS-HGS were performed within 14 days.
Target Size - 270
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 02 Day
Date of IRB - 2026 Year 03 Month 25 Day
Anticipated trial start date - 2026 Year 03 Month 25 Day
Last follow-up date - 2027 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070254
Disclaimer: Curated by HT Syndication.
