Showa Inan General hospital
Komagane, Nagano, 399-4191, Japan
Location status: Recruiting
Recruiting
NCT Number: NCT05363345
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
bile duct stone removal
DeviceCommon bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.
Primary outcomes
-
Percentage of stones cleared
Time frame: Procedure time
Percentage of stones cleared is evaluated after the completion of procedure.
Secondary outcomes
-
Total procedural time
Time frame: Procedure time
Total procedure time is measured.
-
the number of adverse events
Time frame: Procedure time
Adverse events are evaluated after the completion of procedure.
-
the numbers of morbidities and mortality
Time frame: 30 days
Morbidities and mortality is evaluated within 30 days after the completion of procedure.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Akira Horiuchi
Other
Registry information
Official study title
Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 5, 2022
- Registry last updated
- May 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.