An observational study in Choledochal Cyst, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational
This study is a multicenter, bidirectional cohort study aimed at continuously enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for IVa biliary dilatation (BD). Based on this cohort, the study seeks to compare the perioperative risks, long-term outcomes, and quality of life of type IVa BD following surgical treatment, to establish standardized surgical treatment strategies for type IVa BD.
Biliary dilatation (BD) is a common complex benign biliary disease. The incidence rate in Asia is one of every 1000 individuals, and the incidence rate in Europe and America is about one of every 50,000-150,000 individuals. Type IVa BD was the most commonly intrahepatic BD and the second most commonly identifiable cyst type. According to the Todani classification of congenital type IVa represents a combination of intra-and extrahepatic cystic ectasias.
However, there is still significant controversy regarding the surgical treatment approaches for this disease. Current treatment methods mainly include hepaticojejunostomy and hepatectomy. On the one hand, studies suggest that performing hepaticojejunostomy while relieving hilar bile duct stricture is sufficient. Previous research has reported that intrahepatic bile duct cysts may regress after hepaticojejunostomy. However, recent studies have described that type IV-A bile duct (BD) patients may develop long-term complications such as intrahepatic bile duct stones, anastomotic stricture, and cholangitis after hepatojejunostomy, although the specific incidence rates remain unclear. On the other hand, only a few small-series studies have reported that hepatectomy may achieve satisfactory efficacy in treating intrahepatic BD. Nevertheless, other studies have shown that 30% of patients may develop postoperative intrahepatic bile duct stones. Considering that this procedure is a higher-risk surgery compared to bilioenteric anastomosis, its effectiveness and safety in the treatment of type IVa BD introduce greater uncertainty.
This study aims at enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for IVa BDs. Based on this cohort, the study seeks to compare the perioperative risks, long-term outcomes, and quality of life of type IVa BD following surgical treatment, to establish standardized surgical treatment strategies for type IVa BD.
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
This study's planned enrollment of 1,500 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.
Counted across the registry records on this site, refreshed daily.
All patients with a definitive diagnosis of Todani type IVa biliary dilation in the participating centers
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group included patients with type IVa BD who underwent liver resection, extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy
This group included patients with type IVa BD who underwent extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy
Long-term complication-free survival (LCFS)
For patients who have undergone surgical treatment, the occurrences of long-term postoperative complications include recurrent cholangitis, intrahepatic bile duct stones, stenosis of the bilioenteric anastomosis, and other such conditions
Time frame: After 30 or 90 days of surgery
Overall perioperative complication rate
The occurrence of perioperative complications, including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others
Time frame: Within 30 or 90 days postoperatively
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation
Time frame: Through study completion, an average of 1 year
Mayo Score
Long-term outcome was evaluated according to the dedicated clinical evaluation score reported by the Mayo Clinic: excellent, if the patient remained free of symptoms without further reintervention; good, if the patient had occasional and mild episodes of cholangitis or pancreatitis, which were not impairing the quality of life; fair, if the patient had repeated episodes of cholangitis or pancreatitis,or portal hypertension without further reintervention; poor, if the patient required later biliary or liver-related surgical procedures, developed biliary cirrhosis or complications because of portal hypertension, or died from cyst-related malignancy or liver and biliary-related complications.
Time frame: Through study completion, an average of 6 months
Severe perioperative complication rate
The occurrence of severe perioperative complications (Clavien-Dindo grading ≥ III), including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others.
Time frame: Within 30 or 90 days postoperatively
Reoperation rate
The occurrence of reoperation after surgery
Time frame: After 30 or 90 days of surgery
Plan to share: No
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Ran from Jul 2025 to primary completion in Jul 2025, 0 months.
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