Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060980) titled 'A novel fine-caliber strategy for EUS-guided hepaticogastrostomy using a 22-gauge needle and 0.018-inch guidewire: a multicenter prospective study' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Osaka Medical and Pharmaceutical University
Condition:
Condition - Biliary stricture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Technical feasibility
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - 22G, 0.018-inch guidewire
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients with biliary stricture in whom Endoscopic Retrograde Cholangiopancreatography is difficult or unsuccessful
Age >18 years and <99 years at the time of enrollment
Written informed consent obtained from the patient prior to participation in the study
Key exclusion criteria - Exclusion criteria:
Patients with severe bleeding tendency or pregnancy
Patients who have already undergone alternative biliary drainage procedures
Target Size - 20
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2026 Year 03 Month 11 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2030 Year 11 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069780
Disclaimer: Curated by HT Syndication.
