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Research on the Application of Biliary Blockage Device Based on the IDEAL Framework in Percutaneous Transhepatic Cholangioscopy—Phase 2b (Multicenter Randomized Controlled Trial)

Research on the Application of Biliary Blockage Device Based on the IDEAL Framework in Percutaneous Transhepatic Cholangioscopy—Phase 2b (Multicenter Randomized Controlled Trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100884
Enrollment
Unknown
Registered
2025-04-16
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Intrahepatic and extrahepatic bile duct stones

Interventions

embolization group:The biodegradable biliary blockage is deployed to embolize the puncture tract. Post percutaneous transhepatic cholangioscopy (PTCS), the blockage is fabricated using absorbable mate
Drainage group:Following percutaneous transhepatic cholangioscopy (PTCS), a T-tube rubber catheter with comparable diameter to the access sheath is:(1)Trimmed to an optimal shape with 2-3 side holes c

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 105 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed Intrahepatic and/or extrahepatic bile duct stones by imaging (ultrasound, CT, or MRI); 2. Requiring PTCS for hepatolithiasis treatment; 3. Age >=18 years; 4. No contraindications to surgery or anesthesia; 5. Written informed consent obtained from both the patient and family.

Exclusion criteria

Exclusion criteria: 1. Child-Pugh Class C liver function; 2. Acute obstructive suppurative cholangitis (AOSC) requiring emergency intervention; 3. Significant hepatic atrophy; 4. Confirmed or suspected biliary tract malignancy; 5. Intraoperative discovery of significant strictures requiring stent placement; 6. Residual stones necessitating secondary surgery; 7. Incomplete purulent bile drainage requiring continued drainage

Design outcomes

Primary

MeasureTime frame
Technical success rate;clinical success rate;postoperative complications rate;

Secondary

MeasureTime frame
postoperative pain;Postoperative Hospital Stay;Hospitalization Costs;

Countries

China

Contacts

Public ContactRongxing Zhou

West China Hospital, Sichuan University

RongxingZhou@126.com+86 189 8060 2218

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026