Tokyo, Feb. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060559) titled 'Endoscopic ultrasound-guided rendezvous technique versus early precut papillotomy for difficult bile duct cannulation during endoscopic retrograde cholangiopancreatography: a multicenter randomized controlled trial' on Feb. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - University of Toyama
Condition:
Condition - Diseases for which ERC was attempted for the purpose of cholangiography
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To determine and compare the first session technical success for biliary access of EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
To determine the adverse event rates of EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP
To determine the rate of rescue procedures needed in patients with failed biliary access by the assigned study technique
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - EUS-guided rendezvous technique for difficult biliary cannulation
Interventions/Control_2 - Precut papillotomy as the standard salvage technique for difficult biliary cannulation
Eligibility:
Age-lower limit - 18
years-old
1.5) and thrombocytopenia (platelet < 50,000) by blood product transfusion
Pregnant patients
Target Size - 188
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 03 Day
Anticipated trial start date - 2026 Year 02 Month 09 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069273
Disclaimer: Curated by HT Syndication.
