Actively Recruiting
Efficacy and Safety of Surgical Treatment for Type IVa Congenital Biliary Dilatation: A Multi-center Cohort Study
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2025-07-17
1500
Participants Needed
1
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates patients with type IVa biliary dilatation (BD), a complex benign bile duct condition affecting both the intra- and extrahepatic bile ducts. The study aims to build a Chinese patient cohort by enrolling participants from 25 medical centers across China. It seeks to compare surgical treatment approaches for type IVa BD, focusing on perioperative risks, long-term health outcomes, and quality of life to help develop standardized surgical strategies for this condition. Participants with type IVa BD receive one of two surgical treatments: liver resection combined with extrahepatic bile duct removal and Roux-en-Y hepaticojejunostomy, or extrahepatic bile duct removal with Roux-en-Y hepaticojejunostomy alone. These two groups allow comparison of different surgical methods to evaluate their safety and effectiveness. The study continuously enrolls patients and collects comprehensive data throughout their treatment and follow-up periods. During the study, patients are observed for complications occurring within 30 or 90 days after surgery, including long-term complication-free survival. Researchers will also assess rates of malignant transformation, perioperative complications, severity of complications, and the need for reoperations. Quality of life and functional status are monitored using tools like the Mayo Score over an average of six months. The study follows participants up to one year or more, aiming to gather detailed outcome and safety data to inform future treatment decisions for type IVa BD.
CONDITIONS
Brief Title
Efficacy and Safety of Surgical Treatment for Type IVa CBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Todani type IVa biliary dilatation
- Patients aged between 0 and 80 years, any gender
- Patients undergoing their first surgery for biliary dilatation
You will not qualify if you...
- Presence of abnormal intrapancreatic bile duct
- Roux-loop length outside 40-60 cm for adults or 15-30 cm for children
- Having non-relevant surgical interventions
- Pathologically confirmed cancer
- Unresolved choledocholithiasis, bile duct stenosis, or intrahepatic bile duct stones during surgery
- Unavailable follow-up information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days post-surgery
Participants undergo surgical treatment for type IVa biliary dilatation, either liver resection with extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy or extrahepatic bile duct resection with Roux-en-Y hepaticojejunostomy, followed by immediate post-operative care.
Visits during hospital stay and follow-up visits within 90 days
Duration - Up to 1 year
Participants are monitored for long-term outcomes including complication-free survival, malignant transformation, and quality of life for up to 1 year after surgery.
Periodic follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
Research Team
C
Changzhen Yang, MD
S
Shuo Jin, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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