Comparing two types of catheters for removing bile duct stones
Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
NA · Showa Inan General Hospital · NCT05363345
This study tests whether a new type of catheter can remove larger bile duct stones better than the standard catheter for patients with these stones.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Showa Inan General Hospital (other) |
| Locations | 1 site (Komagane, Nagano) |
| Trial ID | NCT05363345 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of the Vortic Catch V basket catheter against a standard ordinary basket catheter in removing bile duct stones that are 10 mm or larger. Patients suspected of having or confirmed to have common bile duct stones will be randomly assigned to receive one of the two catheter types during the procedure. The study will evaluate the success rate of stone removal using these two different catheters, providing insights into which method may be more effective for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with suspected or known common bile duct stones that are 10 mm or larger and who have undergone endoscopic papillary balloon dilation.
Not a fit: Patients experiencing septic shock, coagulopathy, or suspected malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved techniques for the removal of bile duct stones, enhancing patient outcomes and reducing complications.
How similar studies have performed: While there may be existing studies on catheter effectiveness, this specific comparison of the Vortic Catch V basket catheter versus ordinary basket catheter is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Komagane, Nagano
- Showa Inan General hospital — Komagane, Nagano, Japan (RECRUITING)
Study contacts
- Study coordinator: Akira Horiuchi, MD
- Email: horiuchi.akira@sihp.jp
- Phone: 09021684311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Randomized Study