Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst (CDCPS)

Guangzhou Women and Children's Medical Center

Status: Not yet enrolling

Conditions: Choledochal Cyst

Treatments: Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05620485

521123

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

prenatally diagnosed CDC

Experimental group

Description:

All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.

Treatment:

Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy