Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones

Akira Horiuchi

Status: Enrolling

Conditions: Randomized Study

Treatments: Device: bile duct stone removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05363345

Vortic Catch V

Details and patient eligibility

About

Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
• endoscopic papillary balloon dilation (EPLBD) was performed.

Exclusion criteria

• septic shock
• coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control),
• <platelet count 50,000 / L
• suspected or confirmed malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Vortic Catch V basket catheter

Experimental group

Description:

Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter following endoscopic papillary large balloon dilation.

Treatment:

Device: bile duct stone removal

ordinary basket catheter

Active Comparator group

Description:

Common bile duct stones (≧ 10 mm) are removed by using ordinary basket catheter following endoscopic papillary large balloon dilation.

Treatment:

Device: bile duct stone removal