An interventional study of laparoscopic-assisted CDC excision and hepaticojejunostomy in Choledochal Cyst, sponsored by Guangzhou Women and Children's Medical Center. Not yet recruiting. Open to participants aged 0 Months to 3 Months. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Guangzhou Women and Children's Medical Center · Not applicable, Interventional, and Treatment
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.
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.
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
Browse Choledochal Cyst studies →Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Unable to tolerate surgery after birth
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.
preoperative complications
number of participants progressed to CDC-related symptoms before operative intervention
Time frame: pre-intervention
preoperative complications
number of participants with cyst rupture before operative intervention
Time frame: pre-intervention
preoperative complications
aspartate aminotransferase (U/L)
Time frame: 1 week before surgery
preoperative complications
alanine aminotransferase (U/L)
Time frame: 1 week before surgery
preoperative complications
γ-glutamyl transpeptidase (U/L)
Time frame: 1 week before surgery
preoperative complications
Serum Bilirubin (μmol/L）
Time frame: 1 week before surgery
short-term complications
number of participants with post-operative anastomotic leak
Time frame: 1 weak after surgery
short-term complications
number of participants with postoperative hemorrhage
Time frame: 1 weak after surgery
short-term complications
aspartate aminotransferase (U/L)
Time frame: 1 weak after surgery
short-term complications
alanine aminotransferase (U/L)
Time frame: 1 weak after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Time frame: 1 weak after surgery
short-term complications
Serum Bilirubin (μmol/L）
Time frame: 1 weak after surgery
short-term complications
aspartate aminotransferase (U/L)
Time frame: 3 months after surgery
short-term complications
alanine aminotransferase (U/L)
Time frame: 3 months after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Time frame: 3 months after surgery
short-term complications
Serum Bilirubin (μmol/L）
Time frame: 3 months after surgery
short-term complications
aspartate aminotransferase (U/L)
Time frame: 6 months after surgery
short-term complications
alanine aminotransferase (U/L)
Time frame: 6 months after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Time frame: 6 months after surgery
short-term complications
Serum Bilirubin (μmol/L）
Time frame: 6 months after surgery
short-term complications
number of participants with postoperative wound infection
Time frame: 1 month after surgery
Long-term complications
number of participants with anastomotic stricture
Time frame: 3 years after surgery
length of stay
length of hospital stay
Time frame: 1 month after surgery
duration of ventilator support
duration of ventilator support
Time frame: 1 month after surgery
length of nutritional support in hospital
length of nutritional support in hospital
Time frame: 1 month after surgery
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Nov 2022; primary completion for Nov 2025, 36 months later.
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Guangzhou Women and Children's Medical Center