Efficacy and Safety of Surgical Treatment for Type IVa CBD

Beijing Tsinghua Chang Gung Hospital

Status: Not yet enrolling

Conditions: Choledochal Cyst

Study type: Observational

Funder types: Other

Identifiers

NCT07036848

24637-0-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have been diagnosed with Todani type IVa BD.
2. Patients aged between 0 and 80 years old, regardless of gender.
3. First-time receipt of surgery.

Exclusion criteria

1. With abnormal intrapancreatic bile duct
2. Inappropriate Roux-loop length (outside the range of 40-60 cm for adults and 15-30 cm for children)
3. With non-relevant surgical interventions
4. Pathologically confirmed carcinogenesis
5. Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure.
6. Unavailable follow-up information.

Trial design

1,500 participants in 2 patient groups

Liver Resection Group

Description:

This group included patients with type IVa BD who underwent liver resection, extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy

Hepaticojejunostomy Group

Description:

This group included patients with type IVa BD who underwent extrahepatic bile duct resection and Roux-en-Y hepaticojejunostomy