Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst

Study Overview
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Brief Summary
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In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

Detailed Description
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A choledochal cyst (CDC) is a congenital anomaly of the biliary system, which is more common in the Asian population. If a CDC is not diagnosed and treated promptly, it often leads to a series of serious complications, including cholangitis, cyst rupture, cholestatic cirrhosis, and even cholangiocarcinoma. Infants with a postnatal diagnosis of CDC often present with symptoms, and to avoid the occurrence of serious complications, operative correction should be performed as soon as possible when their clinical conditions allow. However, in the current era with the improvement of prenatal screening technology, an increasing number of choledochal cysts are diagnosed prenatally in the fetus. In developed countries, as many as 15% of choledochal cysts are found before birth. Some of these children receive intervention when they are asymptomatic at an early stage, while some have progressed to CDC-related symptoms before operative correction. The timing of operation for children with a prenatal diagnosis of CDC remains controversial. The investigators previous study showed that it is more advantageous to receive surgical treatment in the asymptomatic period for patients with prenatally diagnosed CDC. In addition, the age at operation (months) appears to be unrelated to intraoperative and postoperative complications, which is distinct from previous studies. More interestingly, the investigators found that a specific cyst size (length > 5.2 cm and width > 4.1 cm) suggested that clinical symptoms might appear and that the surgery should be performed as soon as clinically safe to proceed. Therefore, in this study, the investigators tried to select the operation time according to the cyst size and evaluate the treatment effect.

Official Title
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Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst：A Single-center Prospective Study

Conditions
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Choledochal Cyst

Intervention / Treatment
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* Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with a prenatal and postnatal diagnosis with CDC Prenatal and postnatal hepatobiliary ultrasound data were complete Age of visit < 3 months Exclusion Criteria: Unable to tolerate surgery after birth

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prenatally diagnosed CDC<br>All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy. | Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy<br>* After birth, the liver and gallbladder ultrasound were regularly rechecked. If the maximum diameter of the cyst was greater than 5 cm, surgery was performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preoperative complications | number of participants progressed to CDC-related symptoms before operative intervention | pre-intervention | 
| preoperative complications | number of participants with cyst rupture before operative intervention | pre-intervention | 
| preoperative complications | aspartate aminotransferase (U/L) | 1 week before surgery | 
| preoperative complications | alanine aminotransferase (U/L) | 1 week before surgery | 
| preoperative complications | γ-glutamyl transpeptidase (U/L) | 1 week before surgery | 
| preoperative complications | Serum Bilirubin (μmol/L） | 1 week before surgery | 
| short-term complications | number of participants with post-operative anastomotic leak | 1 weak after surgery | 
| short-term complications | number of participants with postoperative hemorrhage | 1 weak after surgery | 
| short-term complications | aspartate aminotransferase (U/L) | 1 weak after surgery | 
| short-term complications | alanine aminotransferase (U/L) | 1 weak after surgery | 
| short-term complications | γ-glutamyl transpeptidase (U/L) | 1 weak after surgery | 
| short-term complications | Serum Bilirubin (μmol/L） | 1 weak after surgery | 
| short-term complications | aspartate aminotransferase (U/L) | 3 months after surgery | 
| short-term complications | alanine aminotransferase (U/L) | 3 months after surgery | 
| short-term complications | γ-glutamyl transpeptidase (U/L) | 3 months after surgery | 
| short-term complications | Serum Bilirubin (μmol/L） | 3 months after surgery | 
| short-term complications | aspartate aminotransferase (U/L) | 6 months after surgery | 
| short-term complications | alanine aminotransferase (U/L) | 6 months after surgery | 
| short-term complications | γ-glutamyl transpeptidase (U/L) | 6 months after surgery | 
| short-term complications | Serum Bilirubin (μmol/L） | 6 months after surgery | 
| short-term complications | number of participants with postoperative wound infection | 1 month after surgery | 
| Long-term complications | number of participants with anastomotic stricture | 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | length of hospital stay | 1 month after surgery | 
| duration of ventilator support | duration of ventilator support | 1 month after surgery | 
| length of nutritional support in hospital | length of nutritional support in hospital | 1 month after surgery |