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Surgical Treatment Safety and Effectiveness for Type IVa Congenital Biliary Dilation A Multicenter Study Comparing Liver Resection and Hepaticojejunostomy Outcomes in China
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
Research Team
C
Changzhen Yang, MD
S
Shuo Jin, PhD
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