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Clinical study on the application of biliary occluder based on IDEAL framework in percutaneous transhepatic choledochoscopy—Phase 1

Clinical study on the application of biliary occluder based on IDEAL framework in percutaneous transhepatic choledochoscopy—Phase 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086210
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Hepatolithiasis

Interventions

Biliary blockage:Use absorbable materials (hemostatic sponge, absorbable hemostatic gauze, absorbable sutures, external freeze-dried human fibrin adhesive, etc.) to make a biliary occluder, and place

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Hepatolithiasis was diagnosed by CT, magnetic resonance cholangiopancreatography, cholangiography and other examinations ; (2) Aged 18-70 years old; (3) The general condition is good, there is no organic damage or dysfunction of important organs, and the person can tolerate general anesthesia; (4) Preoperative liver function is Child-Pugh class A or class B; (5) Normal coagulation function; (6) Treatment of hepatolithiasis through PTCS; (7) Informed consent of the patient and family members.

Exclusion criteria

Exclusion criteria: (1) Patients with acute obstructive suppurative cholangitis who require emergency surgery; (2) Patients with liver atrophy or intrahepatic bile duct cancer; (3) Acute stage of biliary tract infection; (4) Biliary stenosis that requires support.

Design outcomes

Primary

MeasureTime frame
Perioperative mortality;Biliary complications;Operative complications;Residual rate of stones;

Secondary

MeasureTime frame
Pain on the second day after surgery;Postoperative hospital stay time;Hospitalization expenses;Operation time;

Countries

China

Contacts

Public ContactRongxing Zhou

West China Hospital, Sichuan University

rongxingzhou@126.com+86 180 3080 9527

Outcome results

None listed

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