Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst:A Single-center Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- short-term complications
研究概览
简要总结
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with a prenatal and postnatal diagnosis with CDC
- •Prenatal and postnatal hepatobiliary ultrasound data were complete
- •Age of visit < 3 months
排除标准
- •Unable to tolerate surgery after birth
结局指标
主要结局
short-term complications
时间窗: 1 month after surgery
number of participants with postoperative wound infection
Long-term complications
时间窗: 3 years after surgery
number of participants with anastomotic stricture
preoperative complications
时间窗: 1 week before surgery
aspartate aminotransferase (U/L)
次要结局
- length of nutritional support in hospital(1 month after surgery)
- length of stay(1 month after surgery)
- duration of ventilator support(1 month after surgery)
研究者
Xisi Guan
Clinical attending doctor
Guangzhou Women and Children's Medical Center
