Tokyo, July 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062135) titled 'Precut-first Strategy versus Direct EUS-guided Rendezvous Strategy for Difficult Biliary Cannulation: A Multicenter Retrospective Study' on July 6.
Study Type:
Observational
Primary Sponsor:
Institute - University of Tsukuba Hospital
Condition:
Condition - Difficult Biliary Cannulation (Endoscopic Retrograde Cholangiopancreatography in Naive Papilla)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the optimal salvage strategy by analyzing the clinical outcomes of precut papillotomy and EUS-guided rendezvous (EUS-RV) in real-world practice.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients who underwent precut papillotomy or endoscopic ultrasound-guided rendezvous (EUS-RV) for difficult biliary cannulation in a naive papilla at a participating institution between April 1, 2017, and March 31, 2026.
2) Patients who did not express refusal to participate in the study through the opt-out procedure.
Key exclusion criteria - 1) Patients with altered gastrointestinal anatomy after surgery, excluding Billroth-I reconstruction.
2) Patients with impacted stones in the papilla.
3) Patients in whom the major duodenal papilla cannot be endoscopically visualized.
4) Patients deemed inappropriate for inclusion by the principal investigator.
Target Size - 435
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 05 Month 25 Day
Date of IRB - 2026 Year 06 Month 30 Day
Anticipated trial start date - 2026 Year 07 Month 03 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071101
Disclaimer: Curated by HT Syndication.
