NCT05620485

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 0 Months – 3 Months
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Choledochal Cyst

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-15
• Primary completion: 2025-11-15
• Completion: 2026-11-15
• First posted: 2022-11-17
• Last updated: 2022-11-17