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A randomized controlled trial of a new basket and balloon for common bile duct stone retrieval

A multicenter, open-label, randomized controlled trial to verify the non-inferiority of a novel basket catheter to a balloon catheter in endoscopic common bile duct stone removal

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1072240049
Enrollment
186
Registered
2024-08-19
Start date
2024-08-19
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

Common bile duct stone Common bile duct stone

Interventions

Basket catheter group procedures: Basket stone removal is performed within 8 minutes, and after complete stone removal is confirmed by fluoroscopy, balloon stone removal is performed within 2 minutes.

Sponsors

Ryota Sagami
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who undergo endoscopic stone removal

Exclusion criteria

Exclusion criteria: 1) Patients after gastrointestinal reconstruction other than B-I reconstruction 2) Patients with common bile duct stones of 11 mm or more in diameter 3) Patients with severe bile duct stenosis 4) Patients with bile duct dilatation of 20 mm or more in diameter 5) Patients taking multiple antithrombotic agents other than aspirin alone 6) Patients with coagulopathy (PT-INR>1.5, platelet count<50,000/mm3) 7) Patients with severe cholangitis 8) Patients with severe pancreatitis 9) Patients with a history of large balloon papilla dilation 10) Patients with 6 or more piled stones 11) Patients not suitable for papilla treatment 12) Other patients who the doctor in charge of this study judges to be inappropriate

Design outcomes

Primary

MeasureTime frame
Comparison of technical success rate

Secondary

MeasureTime frame
Comparison of technical success rates for biliary sludge removal Comparison of technical success rates for corner pocket stones Comparison of procedural-related complications (type, severity) Factors related to procedural failure and complications The frequency of basket impaction complications Stone symptoms and frequency of stone recurrence one year after the procedure

Contacts

Public ContactHiroshima Yasuhisa

Oita University

y-hiroshima@oita-u.ac.jp+81-97-549-4411

Outcome results

None listed

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