Clinical Trial: A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction (Japan)

Tokyo, June 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061805) titled 'A Multicenter Prospective Study Evaluating the Safety and Efficacy of Double-Layered Inside Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction' on June 5.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Other

Condition: Condition - Malignant hilar biliary obstruction case Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the safety and efficacy of double-layered inside plastic stents for unresectable malignant hilar biliary obstruction. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Inside plastic stent placement for malignant hilar bile duct obstruction

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients with unresectable malignant hilar biliary obstruction Patients with a pathological diagnosis of malignancy Patients requiring biliary drainage due to abnormal values in any of the following: serum total bilirubin, AST, ALT, ALP, or g-GTP The criteria for abnormal values are as follows Total bilirubin more than 2 mg/dL AST more than 45 IU/L ALT more than 45 IU/L ALP more than 170 IU/L g-GTP more than 75 IU/L Patients undergoing initial bilateral inside plastic stent placement Patients expected to have a prognosis of at least 2 months Patients with Bismuth type II-IV (requiring bilateral biliary drainage) Age more than 18 years Key exclusion criteria - Patients with concomitant distal biliary obstruction Patients with surgically altered anatomy (excluding Billroth I reconstruction) Patients with severe comorbidities affecting other organs Patients in whom biliary cannulation (transpapillary approach) is not feasible Patients with concomitant duodenal obstruction ECOG performance status 4 Patients deemed unsuitable by the treating physician Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 04 Day Date of IRB - 2026 Year 06 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 04 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070725

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