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

Not Applicable

Not yet recruiting

• Conditions: Choledochal Cyst
• Interventions: Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy

• Registration Number: NCT05620485
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

Study Timeline

• Study First Submitted: 2022-10-02
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-12
• Last Update Submitted: 2022-11-12
• Study Start: 2022-11-15
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-17
• Primary Completion: 2025-11-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prenatally diagnosed CDC	laparoscopic-assisted CDC excision and hepaticojejunostomy	All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.

Primary Outcome Measures

Name	Time	Method
preoperative complications	1 week before surgery	Serum Bilirubin (μmol/L）
short-term complications	1 month after surgery	number of participants with postoperative wound infection
Long-term complications	3 years after surgery	number of participants with anastomotic stricture

Secondary Outcome Measures

Name	Time	Method
length of nutritional support in hospital	1 month after surgery	length of nutritional support in hospital
length of stay	1 month after surgery	length of hospital stay
duration of ventilator support	1 month after surgery	duration of ventilator support