An observational study in Congenital Biliary Dilatation, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational
Congenital biliary dilatation affects children and adults and can cause biliary complications and malignancy. Large multicenter data on its clinical characteristics and long-term outcomes are limited. Therefore, we conduct this study to characterize the clinical presentation and long-term outcomes of congenital biliary dilatation and identify factors associated with long-term complications.
Design, Setting, and Participants
Congenital biliary dilatation (CBD) comprises a group of congenital abnormalities involving segmental or diffuse dilatation of the intrahepatic and/or extrahepatic bile ducts. It can present in both children and adults and may lead to cholangitis, pancreatitis, biliary stones, liver injury, and biliary malignancy. Surgical treatment is the mainstay of management, with the operative approach determined by the extent and location of disease. However, treatment does not eliminate the risk of later complications. Previous studies have reported recurrent cholangitis, hepatolithiasis, anastomotic stricture, reoperation, and biliary cancer after surgery.
Evidence on the long-term course of CBD remains limited. Most studies have focused on selected age groups, specific Todani types, individual surgical techniques, or single outcomes. In a multi-institutional study of 394 patients, Soares et al. found differences in presentation and perioperative outcomes between children and adults and reported biliary cancer during follow-up after resection. Other studies have shown that type IVa disease may remain complicated by intrahepatic stones, recurrent cholangitis, and reoperation because abnormal intrahepatic ducts remain after treatment. Type V disease has usually been studied separately because of its different intrahepatic distribution and the need for liver-directed treatment in selected patients. No large multicenter cohort has comprehensively characterized the clinical spectrum and long-term outcomes across the major anatomical phenotypes of CBD.
We therefore conducted a nationwide multicenter cohort study to characterize the clinical features and long-term outcomes of patients with CBD. We examined differences across anatomical types, described perioperative and long-term outcomes after surgery, and evaluated factors associated with long-term complications. Long-term complication-free survival (LCFS) was the primary outcome, defined by the time to the first long-term biliary, pancreatic, hepatic, or malignant complication after surgery.
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
This study's enrollment of 4,341 is above the median of 400 across 14 observational studies indexed under Choledochal Cyst.
Browse Choledochal Cyst studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
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All patients with confirmed CBD were included in the baseline analysis.
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Exclusion Criteria:
Long-term complication-free survival
Long-term complications were defined as events occurring more than 3 months after the initial operation and included recurrent cholangitis, pancreatitis, bilioenteric anastomotic stricture, extrahepatic or intrahepatic bile duct stones, liver atrophy, hepatic decompensation, and postoperative biliary cancer.
Time frame: LCFS was calculated from the date of the initial operation to the first long-term complication or the last available follow-up. Time zero was postoperative Day 1. Time frame was through study completion, an average of 5 years.
Plan to share: No — Concerning patients privacy.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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