Randomized Study
Conditions
Brief summary
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).
Interventions
DEVICEbile duct stone removal
Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter or ordinary basket catheter following endoscopic papillary large balloon dilation.
Sponsors
Akira Horiuchi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of stones cleared | Procedure time | Percentage of stones cleared is evaluated after the completion of procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedural time | Procedure time | Total procedure time is measured. |
| the number of adverse events | Procedure time | Adverse events are evaluated after the completion of procedure. |
| the numbers of morbidities and mortality | 30 days | Morbidities and mortality is evaluated within 30 days after the completion of procedure. |
Countries
Japan
Contacts
CONTACTAkira Horiuchi, MD
Outcome results
None listed