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.
Study Type
OBSERVATIONAL
Enrollment
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGLong-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.
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1,500
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