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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05620485
Acronym
CDCPS
Enrollment
30
Registered
2022-11-17
Start date
2022-11-15
Completion date
2026-11-15
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledochal Cyst

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.

Interventions

PROCEDURElaparoscopic-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.

Sponsors

Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Months to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
preoperative complicationspre-interventionnumber of participants progressed to CDC-related symptoms before operative intervention
short-term complications1 weak after surgerynumber of participants with post-operative anastomotic leak
Long-term complications3 years after surgerynumber of participants with anastomotic stricture

Secondary

MeasureTime frameDescription
length of stay1 month after surgerylength of hospital stay
duration of ventilator support1 month after surgeryduration of ventilator support
length of nutritional support in hospital1 month after surgerylength of nutritional support in hospital

Contacts

Primary Contactxisi guan
545280987@qq.com13926155230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026