NCT07036848

Efficacy and Safety of Surgical Treatment for Type IVa CBD

The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Choledochal Cyst

Timeline

• Start date: 2025-07-14
• Primary completion: 2025-07-14
• Completion: 2035-07-01
• First posted: 2025-06-25
• Last updated: 2025-07-17

Locations

1 site across 1 country: China