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

Choledochal Cyst Clinical Trial

— CDCPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05620485
• Other study ID #: 521123
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 15, 2026

Study information

• Verified date: November 2022
• Source: Guangzhou Women and Children's Medical Center
• Contact: xisi guan
• Phone: 13926155230
• Email: 545280987[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 3 Months

Eligibility

Inclusion Criteria:

1. Infants with a prenatal and postnatal diagnosis with CDC

2. Prenatal and postnatal hepatobiliary ultrasound data were complete

3. Age of visit < 3 months

Exclusion Criteria:

Unable to tolerate surgery after birth

Related Conditions & MeSH terms

• Choledochal Cyst
• Cysts

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative complications	number of participants progressed to CDC-related symptoms before operative intervention	pre-intervention
Primary	preoperative complications	number of participants with cyst rupture before operative intervention	pre-intervention
Primary	preoperative complications	aspartate aminotransferase (U/L)	1 week before surgery
Primary	preoperative complications	alanine aminotransferase (U/L)	1 week before surgery
Primary	preoperative complications	?-glutamyl transpeptidase (U/L)	1 week before surgery
Primary	preoperative complications	Serum Bilirubin (µmol/L)	1 week before surgery
Primary	short-term complications	number of participants with post-operative anastomotic leak	1 weak after surgery
Primary	short-term complications	number of participants with postoperative hemorrhage	1 weak after surgery
Primary	short-term complications	aspartate aminotransferase (U/L)	1 weak after surgery
Primary	short-term complications	alanine aminotransferase (U/L)	1 weak after surgery
Primary	short-term complications	?-glutamyl transpeptidase (U/L)	1 weak after surgery
Primary	short-term complications	Serum Bilirubin (µmol/L)	1 weak after surgery
Primary	short-term complications	aspartate aminotransferase (U/L)	3 months after surgery
Primary	short-term complications	alanine aminotransferase (U/L)	3 months after surgery
Primary	short-term complications	?-glutamyl transpeptidase (U/L)	3 months after surgery
Primary	short-term complications	Serum Bilirubin (µmol/L)	3 months after surgery
Primary	short-term complications	aspartate aminotransferase (U/L)	6 months after surgery
Primary	short-term complications	alanine aminotransferase (U/L)	6 months after surgery
Primary	short-term complications	?-glutamyl transpeptidase (U/L)	6 months after surgery
Primary	short-term complications	Serum Bilirubin (µmol/L)	6 months after surgery
Primary	short-term complications	number of participants with postoperative wound infection	1 month after surgery
Primary	Long-term complications	number of participants with anastomotic stricture	3 years after surgery
Secondary	length of stay	length of hospital stay	1 month after surgery
Secondary	duration of ventilator support	duration of ventilator support	1 month after surgery
Secondary	length of nutritional support in hospital	length of nutritional support in hospital	1 month after surgery