CDCPS: Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
Study Details
Study Description
Brief Summary
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: prenatally diagnosed CDC All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy. |
Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy
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.
|
Outcome Measures
Primary Outcome Measures
- preoperative complications [pre-intervention]
number of participants progressed to CDC-related symptoms before operative intervention
- preoperative complications [pre-intervention]
number of participants with cyst rupture before operative intervention
- preoperative complications [1 week before surgery]
aspartate aminotransferase (U/L)
- preoperative complications [1 week before surgery]
alanine aminotransferase (U/L)
- preoperative complications [1 week before surgery]
γ-glutamyl transpeptidase (U/L)
- preoperative complications [1 week before surgery]
Serum Bilirubin (μmol/L）
- short-term complications [1 weak after surgery]
number of participants with post-operative anastomotic leak
- short-term complications [1 weak after surgery]
number of participants with postoperative hemorrhage
- short-term complications [1 weak after surgery]
aspartate aminotransferase (U/L)
- short-term complications [1 weak after surgery]
alanine aminotransferase (U/L)
- short-term complications [1 weak after surgery]
γ-glutamyl transpeptidase (U/L)
- short-term complications [1 weak after surgery]
Serum Bilirubin (μmol/L）
- short-term complications [3 months after surgery]
aspartate aminotransferase (U/L)
- short-term complications [3 months after surgery]
alanine aminotransferase (U/L)
- short-term complications [3 months after surgery]
γ-glutamyl transpeptidase (U/L)
- short-term complications [3 months after surgery]
Serum Bilirubin (μmol/L）
- short-term complications [6 months after surgery]
aspartate aminotransferase (U/L)
- short-term complications [6 months after surgery]
alanine aminotransferase (U/L)
- short-term complications [6 months after surgery]
γ-glutamyl transpeptidase (U/L)
- short-term complications [6 months after surgery]
Serum Bilirubin (μmol/L）
- short-term complications [1 month after surgery]
number of participants with postoperative wound infection
- Long-term complications [3 years after surgery]
number of participants with anastomotic stricture
Secondary Outcome Measures
- length of stay [1 month after surgery]
length of hospital stay
- duration of ventilator support [1 month after surgery]
duration of ventilator support
- length of nutritional support in hospital [1 month after surgery]
length of nutritional support in hospital
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangzhou Women and Children's Medical Center
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 521123