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Not yet recruiting NCT05620485

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

No phase Interventional Choledochal Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: laparoscopic-assisted CDC excision and hepaticojejunostomy.
Who it may be relevant to
Registry conditions: Choledochal Cyst. Basic parameters: 0 months — 3 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Procedure laparoscopic-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.

Primary outcome measures

  • preoperative complications [Time frame: pre-intervention]
  • preoperative complications [Time frame: pre-intervention]
  • preoperative complications [Time frame: 1 week before surgery]
  • preoperative complications [Time frame: 1 week before surgery]
  • preoperative complications [Time frame: 1 week before surgery]
  • preoperative complications [Time frame: 1 week before surgery]
  • short-term complications [Time frame: 1 weak after surgery]
  • short-term complications [Time frame: 1 weak after surgery]
  • short-term complications [Time frame: 1 weak after surgery]
  • short-term complications [Time frame: 1 weak after surgery]
Secondary outcome measures (3)
  • length of stay [Time frame: 1 month after surgery]
  • duration of ventilator support [Time frame: 1 month after surgery]
  • length of nutritional support in hospital [Time frame: 1 month after surgery]

Eligibility criteria

Inclusion criteria

  • Infants with a prenatal and postnatal diagnosis with CDC
  • Prenatal and postnatal hepatobiliary ultrasound data were complete
  • Age of visit < 3 months

Exclusion criteria

Unable to tolerate surgery after birth

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05620485 · 521123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗