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Recruiting NCT05363345

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

No phase Interventional Randomized Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bile duct stone removal.
Who it may be relevant to
Registry conditions: Randomized Study. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones

Overview

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

  • Device bile 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.

Primary outcome measures

  • Percentage of stones cleared [Time frame: Procedure time]
Secondary outcome measures (3)
  • Total procedural time [Time frame: Procedure time]
  • the number of adverse events [Time frame: Procedure time]
  • the numbers of morbidities and mortality [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Showa Inan General hospital — Komagane

Identifiers

NCT: NCT05363345 · Vortic Catch V

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗