跳至主要内容
临床试验/NCT05620485
NCT05620485尚未招募不适用

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

Guangzhou Women and Children's Medical Center0 个研究点目标入组 30 人开始时间: 2022年11月15日最近更新:
适应症

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

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

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xisi Guan

Clinical attending doctor

Guangzhou Women and Children's Medical Center

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