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Trial Title:
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
NCT ID:
NCT05620485
Condition:
Choledochal Cyst
Conditions: Official terms:
Cysts
Choledochal Cyst
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic-assisted CDC excision and hepaticojejunostomy
Description:
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.
Arm group label:
prenatally diagnosed CDC
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.
Criteria for 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
Gender:
All
Minimum age:
0 Months
Maximum age:
3 Months
Healthy volunteers:
No
Start date:
November 15, 2022
Completion date:
November 15, 2026
Lead sponsor:
Agency:
Guangzhou Women and Children's Medical Center
Agency class:
Other
Source:
Guangzhou Women and Children's Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620485
