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NCT Number: NCT05620485

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

In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic-assisted CDC excision and hepaticojejunostomy

Procedure

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 outcomes

  1. preoperative complications

    Time frame: pre-intervention

    number of participants progressed to CDC-related symptoms before operative intervention

  2. preoperative complications

    Time frame: pre-intervention

    number of participants with cyst rupture before operative intervention

  3. preoperative complications

    Time frame: 1 week before surgery

    aspartate aminotransferase (U/L)

  4. preoperative complications

    Time frame: 1 week before surgery

    alanine aminotransferase (U/L)

  5. preoperative complications

    Time frame: 1 week before surgery

    γ-glutamyl transpeptidase (U/L)

  6. preoperative complications

    Time frame: 1 week before surgery

    Serum Bilirubin (μmol/L)

  7. short-term complications

    Time frame: 1 weak after surgery

    number of participants with post-operative anastomotic leak

  8. short-term complications

    Time frame: 1 weak after surgery

    number of participants with postoperative hemorrhage

  9. short-term complications

    Time frame: 1 weak after surgery

    aspartate aminotransferase (U/L)

  10. short-term complications

    Time frame: 1 weak after surgery

    alanine aminotransferase (U/L)

  11. short-term complications

    Time frame: 1 weak after surgery

    γ-glutamyl transpeptidase (U/L)

  12. short-term complications

    Time frame: 1 weak after surgery

    Serum Bilirubin (μmol/L)

  13. short-term complications

    Time frame: 3 months after surgery

    aspartate aminotransferase (U/L)

  14. short-term complications

    Time frame: 3 months after surgery

    alanine aminotransferase (U/L)

  15. short-term complications

    Time frame: 3 months after surgery

    γ-glutamyl transpeptidase (U/L)

  16. short-term complications

    Time frame: 3 months after surgery

    Serum Bilirubin (μmol/L)

  17. short-term complications

    Time frame: 6 months after surgery

    aspartate aminotransferase (U/L)

  18. short-term complications

    Time frame: 6 months after surgery

    alanine aminotransferase (U/L)

  19. short-term complications

    Time frame: 6 months after surgery

    γ-glutamyl transpeptidase (U/L)

  20. short-term complications

    Time frame: 6 months after surgery

    Serum Bilirubin (μmol/L)

  21. short-term complications

    Time frame: 1 month after surgery

    number of participants with postoperative wound infection

  22. Long-term complications

    Time frame: 3 years after surgery

    number of participants with anastomotic stricture

Secondary outcomes

  1. length of stay

    Time frame: 1 month after surgery

    length of hospital stay

  2. duration of ventilator support

    Time frame: 1 month after surgery

    duration of ventilator support

  3. length of nutritional support in hospital

    Time frame: 1 month after surgery

    length of nutritional support in hospital

Study contacts

Contact information is provided by the study sponsor or research team.

xisi guan

CONTACT

[email protected]

13926155230

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

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

Acronym: CDCPS

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 17, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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