Efficacy and Safety of Surgical Treatment for Type IVa CBD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Choledochal Cyst. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of Surgical Treatment in Type IVa Congenital Biliary Dilation: A Multi-center Cohort Study
Overview
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.
Primary outcome measures
- Long-term complication-free survival (LCFS) [Time frame: After 30 or 90 days of surgery]
Secondary outcome measures (5)
- Overall perioperative complication rate [Time frame: Within 30 or 90 days postoperatively]
- Malignant transformation rate [Time frame: Through study completion, an average of 1 year]
- Mayo Score [Time frame: Through study completion, an average of 6 months]
- Severe perioperative complication rate [Time frame: Within 30 or 90 days postoperatively]
- Reoperation rate [Time frame: After 30 or 90 days of surgery]
Eligibility criteria
Inclusion criteria
- Patients who have been diagnosed with Todani type IVa BD.
- Patients aged between 0 and 80 years old, regardless of gender.
- First-time receipt of surgery.
Exclusion criteria
- With abnormal intrapancreatic bile duct
- Inappropriate Roux-loop length (outside the range of 40-60 cm for adults and 15-30 cm for children)
- With non-relevant surgical interventions
- Pathologically confirmed carcinogenesis
- Unresolved choledocholithiasis, bile duct stenosis, and Intrahepatic bile duct stones during the procedure.
- Unavailable follow-up information.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tsinghua Changgung Hospital — Beijing
Identifiers
NCT: NCT07036848 · 24637-0-01