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Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study

Evaluation of a novel tornado-shape basket catheter for removing bile duct stones: a multicenter clinical feasibility study - Evaluation of a novel tornado-shape basket

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026951
Enrollment
45
Registered
2017-05-01
Start date
2017-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bile duct stone

Interventions

endoscopic removal of bile duct stones using a novel baslet catheter (FG-V451P, Olympus, Tokyo, Japan)

Sponsors

Teikyo University Mizonokuchi Hospital, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) minimum diameter of the largest bile duct stone measured at ERCP 11 mm or smaller, with no limitation in the number of stones 2) after written informed consent 3) good ADL (ECOG performence status 0-2)

Exclusion criteria

Exclusion criteria: 1) previous gastrectomy,except for Billroth-I reconstruction 2) biliary stenosis 3) recurrent stone in patients with previous ES(widely opened biliary orifice) 4) age younger than 20 years 5) bleeding tendency a) platelet count less than 50,000/mm3, b) international normalized ratio (INR)[1.5] c) patients receiving anticoagulants d) patients with underlying diseases associated with bleeding tendency and coagulopathy 6) unable or not wishing to give informed consent 7) judged by a physician to be inappropriate for inclusion in the study for any other reason

Design outcomes

Primary

MeasureTime frame
complete stone clearance rate at single endocopic session

Secondary

MeasureTime frame
adverse events related to the procedure and their occurrence rates

Countries

Japan

Contacts

Public ContactIchiro Yasuda

Teikyo University Mizonokuchi Hospital Dept. of Gastroenterology

yasudaich@gmail.com044-844-3333

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026