Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061866) titled 'A Randomized Controlled Non-Inferiority Trial Comparing the Efficacy and Safety of 19-Gauge versus 22-Gauge Needle Puncture Approaches in Endoscopic Ultrasound-Guided Hepaticogastrostomy/Hepaticojejunostomy (EUS-HGS/HJS)' on June 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - University of Toyama Hospital
Condition:
Condition - Biliary obstruction
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the non-inferiority of the 22-gauge needle puncture approach compared with the 19-gauge needle puncture approach in EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS) for patients with biliary obstruction unsuitable for or refractory to transpapillary biliary drainage, using technical success rate as the primary endpoint.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - During EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS), biliary puncture and stent placement will be performed using a 19-gauge needle and a 0.025-inch guidewire.
Interventions/Control_2 - During EUS-guided hepaticogastrostomy/hepaticojejunostomy (EUS-HGS/HJS), biliary puncture and stent placement will be performed using a 22-gauge needle and a 0.018-inch guidewire.
Eligibility:
Age-lower limit - 20
years-old
= 1.5.
10. Any patient considered inappropriate by the investigators.
Target Size - 166
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 10 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2028 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070788
Disclaimer: Curated by HT Syndication.
