Choledochal CystCDCPSNCT05620485
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
A study testing laparoscopic-assisted CDC excision and hepaticojejunostomy in people with Choledochal Cyst, run by Guangzhou Women and Children's Medical Center.
Trial summary
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect. Read more about this study
- Who is it for?
- Ages 0 to 3 months
- Conditions the study is for
- Choledochal Cyst
- What is being tested?
- laparoscopic-assisted CDC excision and hepaticojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2022to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a prenatal and postnatal diagnosis with CDC
- Prenatal and postnatal hepatobiliary ultrasound data were complete
- Age of visit < 3 months
Who cannot join
- Unable to tolerate surgery after birth
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst：A Single-center Prospective Study
In this prospective study, we tried to select the operation time according to the cyst size and evaluate the treatment effect.
Read the 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.
- Conditions
- Choledochal Cyst
- Being tested
- laparoscopic-assisted CDC excision and hepaticojejunostomy
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic-assisted CDC excision and hepaticojejunostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| prenatally diagnosed CDC | Experimental | All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy. Receives: Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative complications
number of participants progressed to CDC-related symptoms before operative intervention
Measured: pre-intervention
preoperative complications
number of participants with cyst rupture before operative intervention
Measured: pre-intervention
preoperative complications
aspartate aminotransferase (U/L)
Measured: 1 week before surgery
preoperative complications
alanine aminotransferase (U/L)
Measured: 1 week before surgery
preoperative complications
γ-glutamyl transpeptidase (U/L)
Measured: 1 week before surgery
preoperative complications
Serum Bilirubin (μmol/L）
Measured: 1 week before surgery
short-term complications
number of participants with post-operative anastomotic leak
Measured: 1 weak after surgery
short-term complications
number of participants with postoperative hemorrhage
Measured: 1 weak after surgery
short-term complications
aspartate aminotransferase (U/L)
Measured: 1 weak after surgery
short-term complications
alanine aminotransferase (U/L)
Measured: 1 weak after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Measured: 1 weak after surgery
short-term complications
Serum Bilirubin (μmol/L）
Measured: 1 weak after surgery
short-term complications
aspartate aminotransferase (U/L)
Measured: 3 months after surgery
short-term complications
alanine aminotransferase (U/L)
Measured: 3 months after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Measured: 3 months after surgery
short-term complications
Serum Bilirubin (μmol/L）
Measured: 3 months after surgery
short-term complications
aspartate aminotransferase (U/L)
Measured: 6 months after surgery
short-term complications
alanine aminotransferase (U/L)
Measured: 6 months after surgery
short-term complications
γ-glutamyl transpeptidase (U/L)
Measured: 6 months after surgery
short-term complications
Serum Bilirubin (μmol/L）
Measured: 6 months after surgery
short-term complications
number of participants with postoperative wound infection
Measured: 1 month after surgery
Long-term complications
number of participants with anastomotic stricture
Measured: 3 years after surgery
Secondary outcomes (3)
length of stay
length of hospital stay
Measured: 1 month after surgery
duration of ventilator support
duration of ventilator support
Measured: 1 month after surgery
length of nutritional support in hospital
length of nutritional support in hospital
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledochal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xisi Guan, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620485
- Sponsor's protocol ID
- 521123
- Acronym
- CDCPS
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst：A Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT05620485
- Acronym / sponsor ID
- CDCPS / 521123
- Conditions
- Choledochal Cyst
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prenatally diagnosed CDC | Experimental | Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomyAll patients received laparoscopic-assisted CDC excision and hepaticojejunostomy. |
Who may qualify
- Ages
- 0 to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with a prenatal and postnatal diagnosis with CDC
- Prenatal and postnatal hepatobiliary ultrasound data were complete
- Age of visit < 3 months
Key exclusion criteria (1 listed)
- Unable to tolerate surgery after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic-assisted CDC excision and hepaticojejunostomyAfter birth, the liver and gallbladder ultrasound were regularly rechecked. If the maximum diameter of the cyst was greater than 5 cm, surgery was performed. | Procedure or surgery | prenatally diagnosed CDC |
Primary outcome
preoperative complications
Time frame: pre-intervention
number of participants progressed to CDC-related symptoms before operative intervention
preoperative complications
Time frame: pre-intervention
number of participants with cyst rupture before operative intervention
preoperative complications
Time frame: 1 week before surgery
aspartate aminotransferase (U/L)
preoperative complications
Time frame: 1 week before surgery
alanine aminotransferase (U/L)
preoperative complications
Time frame: 1 week before surgery
γ-glutamyl transpeptidase (U/L)
preoperative complications
Time frame: 1 week before surgery
Serum Bilirubin (μmol/L）
short-term complications
Time frame: 1 weak after surgery
number of participants with post-operative anastomotic leak
short-term complications
Time frame: 1 weak after surgery
number of participants with postoperative hemorrhage
short-term complications
Time frame: 1 weak after surgery
aspartate aminotransferase (U/L)
short-term complications
Time frame: 1 weak after surgery
alanine aminotransferase (U/L)
short-term complications
Time frame: 1 weak after surgery
γ-glutamyl transpeptidase (U/L)
short-term complications
Time frame: 1 weak after surgery
Serum Bilirubin (μmol/L）
short-term complications
Time frame: 3 months after surgery
aspartate aminotransferase (U/L)
short-term complications
Time frame: 3 months after surgery
alanine aminotransferase (U/L)
short-term complications
Time frame: 3 months after surgery
γ-glutamyl transpeptidase (U/L)
short-term complications
Time frame: 3 months after surgery
Serum Bilirubin (μmol/L）
short-term complications
Time frame: 6 months after surgery
aspartate aminotransferase (U/L)
short-term complications
Time frame: 6 months after surgery
alanine aminotransferase (U/L)
short-term complications
Time frame: 6 months after surgery
γ-glutamyl transpeptidase (U/L)
short-term complications
Time frame: 6 months after surgery
Serum Bilirubin (μmol/L）
short-term complications
Time frame: 1 month after surgery
number of participants with postoperative wound infection
Long-term complications
Time frame: 3 years after surgery
number of participants with anastomotic stricture
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Undecided
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ERAS in Choledochal Cyst & Biliary Atresia
Choledochal Cyst Resection, Biliary Atresia, Kasai Portoenterostomy Status
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ARPKD Database Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic-assisted CDC excision and hepaticojejunostomy in people with Choledochal Cyst, run by Guangzhou Women and Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xisi guan (13926155230, 545280987@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative complications (time frame: pre-intervention). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.