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

JRCT ID: jRCT1072240049

Registered date:19/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Common bile duct stone
• Date of first enrollment: 19/08/2024
• Target sample size: 186
• Study type: Interventional

Intervention(s)

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.
Balloon group procedures: Balloon stone removal is performed within 8 minutes, and basket stone removal is performed within 2 minutes.

Outcome(s)

• Primary Outcome: Comparison of technical success rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 95age old
• Gender: Both
• Include criteria: Patients who undergo endoscopic stone removal

Exclude 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

Related Information

• Primary Sponsor: Ryota Sagami