Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063086) titled 'A multicenter observational study to evaluate the incidence of pancreatitis and its associated factors following the double-guidewire technique during biliary cannulation in ERCP' on Sept. 28.

Study Type: Observational

Primary Sponsor: Institute - Iwata City Hospital

Condition: Condition - [Inclusion Criteria] i) Patients undergoing ERCP for the first time ii) Patients in whom the double-guidewire technique (DGT) was used during biliary cannulation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The double-guidewire technique (DGT), in which a second guidewire is used to attempt biliary cannulation while a guidewire is left in the pancreatic duct, is one of the salvage techniques for difficult biliary cannulation during ERCP. Although DGT has been reported to improve biliary cannulation success in difficult cases, it may also increase the risk of post-ERCP pancreatitis (PEP) because of pancreatic guidewire placement and repeated pancreatic manipulation. However, it remains unclear which components of the DGT procedure are associated with the development or severity of PEP. We therefore conducted a multicenter observational study to investigate the risk factors for PEP in patients undergoing DGT. Basic objectives2 - Safety

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - [Inclusion Criteria] i) Patients undergoing ERCP for the first time ii) Patients in whom the double-guidewire technique (DGT) was used during biliary cannulation Key exclusion criteria - [Exclusion Criteria] i) Patients with a history of ERCP Cases in which ERCP had been attempted previously but biliary cannulation was unsuccessful will be regarded as first-time ERCP cases. ii) Patients undergoing ERCP solely for pancreatic duct-related diseases iii) Patients with surgically altered anatomy, excluding Billroth I reconstruction iv) Patients who have undergone prior pancreatic resection v) Patients with pancreaticobiliary maljunction vi) Patients judged by the principal investigator or subinvestigators to be inappropriate for inclusion in this study Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 05 Day Date of IRB - 2026 Year 03 Month 05 Day Anticipated trial start date - 2026 Year 03 Month 05 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=R000069961

Disclaimer: Curated by HT Syndication.