Tokyo, July 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062190) titled 'Comparison of balloon catheter and spiral basket catheter for endoscopic stone extraction in distal common bile duct stones' on July 20.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Pancreatobiliary Advanced Medical Center, Osaka Medical and Pharmaceutical University Hospital

Condition: Condition - Common bile duct stones Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the treatment outcomes of spiral basket catheter and balloon catheter for endoscopic extraction of common bile duct stones measuring 10 mm or smaller with distal location or impacted tendency, and to evaluate the superiority of the spiral basket-first strategy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Balloon catheter group. After biliary cannulation and confirmation of stones by cholangiography, endoscopic sphincterotomy is performed, followed by stone extraction using the assigned balloon catheter. If complete stone extraction cannot be achieved within 10 minutes from insertion of the assigned device into the bile duct, switching to another extraction device or another treatment method is permitted. Interventions/Control_2 - Spiral basket catheter group. After biliary cannulation and confirmation of stones by cholangiography, endoscopic sphincterotomy is performed, followed by stone extraction using the assigned spiral basket catheter. If complete stone extraction cannot be achieved within 10 minutes from insertion of the assigned device into the bile duct, switching to another extraction device or another treatment method is permitted.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Hospitalized patients with common bile duct stones at the participating institutions. 2. Stones located distally or showing impacted tendency. 3. Age 18 years or older and less than 99 years at enrollment. 4. Patients with normal anatomy or Billroth I reconstruction. 5. Written informed consent obtained from the patient. Key exclusion criteria - 1. Surgically altered anatomy other than Billroth I reconstruction. 2. ECOG performance status 4. 3. Patients with bleeding tendency. 4. Patients with concomitant intrahepatic bile duct stones. 5. Patients in whom stones are not confirmed by cholangiography. Target Size - 390

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 20 Day Last follow-up date - 2029 Year 07 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071167

Disclaimer: Curated by HT Syndication.