Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063087) titled 'Risk Factors for Early Recurrent Biliary Obstruction After Multiple Inside Plastic Stent Placement for Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Cohort Study' on Sept. 28.
Study Type:
Observational
Primary Sponsor:
Institute - First Department of Internal Medicine, Gifu University Hospital
Condition:
Condition - Unresectable malignant hilar biliary obstruction
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to clarify the cumulative incidence and risk factors for early recurrent biliary obstruction (RBO) in patients with unresectable malignant hilar biliary obstruction who underwent ERCP-guided placement of multiple inside plastic stents (iPS). These findings may help optimize the timing of scheduled stent exchanges and strategies for biliary drainage.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients aged 18 years or older
2. Patients who underwent multiple inside plastic stent (iPS) placement at the last planned endoscopic biliary drainage (LPEBD) during the initial planned endoscopic drainage for unresectable malignant hilar biliary obstruction between April 1, 2020 and March 31, 2026
Key exclusion criteria - 1. Patients who declined the use of their clinical information through the opt-out process
2. Patients considered inappropriate for inclusion in the study by the investigators
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 01 Day
Date of IRB - 2026 Year 09 Month 02 Day
Anticipated trial start date - 2026 Year 09 Month 02 Day
Last follow-up date - 2033 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071924
Disclaimer: Curated by HT Syndication.