Single-arm Phase 2 multicenter study on the usefulness of a novel guidewire-guided 8-wire basket catheter for common bile duct stones

JRCT ID: jRCT1032200324

Registered date:25/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Common bile duct stones
• Date of first enrollment: 25/01/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Endoscopic common bile duct stone removal using a new guide wire guided 8-wire basket catheter

Outcome(s)

• Primary Outcome: Complete stone removal rate for the new GW-guided 8-wire Nitinol Basket catheter (Medi-Globe 8-Wire Nitinol Basket)
• Secondary Outcome: Stone removal rate by balloon catheter (offset balloon catheter, short wire lumen, proximal type) performed by checking the remaining stones

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Cases scheduled to undergo endoscopic stone removal for common bile duct stones

Exclude criteria

Postoperatively reconstructed intestinal tract cases other than Billroth-I reconstruction.
Cases of bile duct stenosis or cases of bile duct diameter of 30 mm or more.
Cases with bleeding tendency.

Related Information

• Primary Sponsor: Sugimori Kazuya
• Secondary ID(s): UMIN000042019