Clinical trial NCT05620485: Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
Official title: Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst：A Single-center Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Choledochal Cyst
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: preoperative complications
timeFrame: pre-intervention
measure: preoperative complications
timeFrame: pre-intervention
measure: preoperative complications
timeFrame: 1 week before surgery
measure: preoperative complications
timeFrame: 1 week before surgery
measure: preoperative complications
timeFrame: 1 week before surgery
measure: preoperative complications
timeFrame: 1 week before surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 1 weak after surgery
measure: short-term complications
timeFrame: 3 months after surgery
measure: short-term complications
timeFrame: 3 months after surgery
measure: short-term complications
timeFrame: 3 months after surgery
measure: short-term complications
timeFrame: 3 months after surgery
measure: short-term complications
timeFrame: 6 months after surgery
measure: short-term complications
timeFrame: 6 months after surgery
measure: short-term complications
timeFrame: 6 months after surgery
measure: short-term complications
timeFrame: 6 months after surgery
measure: short-term complications
timeFrame: 1 month after surgery
measure: Long-term complications
timeFrame: 3 years after surgery
Secondary outcomes:
measure: length of stay
timeFrame: 1 month after surgery
measure: duration of ventilator support
timeFrame: 1 month after surgery
measure: length of nutritional support in hospital
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
References: