Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst (CDCPS)
Primary Purpose
Choledochal Cyst
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic-assisted CDC excision and hepaticojejunostomy
Sponsored by
About this trial
This is an interventional treatment trial for Choledochal Cyst
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prenatally diagnosed CDC
Arm Description
All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.
Outcomes
Primary Outcome Measures
preoperative complications
number of participants progressed to CDC-related symptoms before operative intervention
preoperative complications
number of participants with cyst rupture before operative intervention
preoperative complications
aspartate aminotransferase (U/L)
preoperative complications
alanine aminotransferase (U/L)
preoperative complications
γ-glutamyl transpeptidase (U/L)
preoperative complications
Serum Bilirubin (μmol/L)
short-term complications
number of participants with post-operative anastomotic leak
short-term complications
number of participants with postoperative hemorrhage
short-term complications
aspartate aminotransferase (U/L)
short-term complications
alanine aminotransferase (U/L)
short-term complications
γ-glutamyl transpeptidase (U/L)
short-term complications
Serum Bilirubin (μmol/L)
short-term complications
aspartate aminotransferase (U/L)
short-term complications
alanine aminotransferase (U/L)
short-term complications
γ-glutamyl transpeptidase (U/L)
short-term complications
Serum Bilirubin (μmol/L)
short-term complications
aspartate aminotransferase (U/L)
short-term complications
alanine aminotransferase (U/L)
short-term complications
γ-glutamyl transpeptidase (U/L)
short-term complications
Serum Bilirubin (μmol/L)
short-term complications
number of participants with postoperative wound infection
Long-term complications
number of participants with anastomotic stricture
Secondary Outcome Measures
length of stay
length of hospital stay
duration of ventilator support
duration of ventilator support
length of nutritional support in hospital
length of nutritional support in hospital
Full Information
NCT ID
NCT05620485
First Posted
October 2, 2022
Last Updated
November 12, 2022
Sponsor
Guangzhou Women and Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05620485
Brief Title
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
Acronym
CDCPS
Official Title
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst:A Single-center Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
November 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Women and Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledochal Cyst
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prenatally diagnosed CDC
Arm Type
Experimental
Arm Description
All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic-assisted CDC excision and hepaticojejunostomy
Intervention 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.
Primary Outcome Measure Information:
Title
preoperative complications
Description
number of participants progressed to CDC-related symptoms before operative intervention
Time Frame
pre-intervention
Title
preoperative complications
Description
number of participants with cyst rupture before operative intervention
Time Frame
pre-intervention
Title
preoperative complications
Description
aspartate aminotransferase (U/L)
Time Frame
1 week before surgery
Title
preoperative complications
Description
alanine aminotransferase (U/L)
Time Frame
1 week before surgery
Title
preoperative complications
Description
γ-glutamyl transpeptidase (U/L)
Time Frame
1 week before surgery
Title
preoperative complications
Description
Serum Bilirubin (μmol/L)
Time Frame
1 week before surgery
Title
short-term complications
Description
number of participants with post-operative anastomotic leak
Time Frame
1 weak after surgery
Title
short-term complications
Description
number of participants with postoperative hemorrhage
Time Frame
1 weak after surgery
Title
short-term complications
Description
aspartate aminotransferase (U/L)
Time Frame
1 weak after surgery
Title
short-term complications
Description
alanine aminotransferase (U/L)
Time Frame
1 weak after surgery
Title
short-term complications
Description
γ-glutamyl transpeptidase (U/L)
Time Frame
1 weak after surgery
Title
short-term complications
Description
Serum Bilirubin (μmol/L)
Time Frame
1 weak after surgery
Title
short-term complications
Description
aspartate aminotransferase (U/L)
Time Frame
3 months after surgery
Title
short-term complications
Description
alanine aminotransferase (U/L)
Time Frame
3 months after surgery
Title
short-term complications
Description
γ-glutamyl transpeptidase (U/L)
Time Frame
3 months after surgery
Title
short-term complications
Description
Serum Bilirubin (μmol/L)
Time Frame
3 months after surgery
Title
short-term complications
Description
aspartate aminotransferase (U/L)
Time Frame
6 months after surgery
Title
short-term complications
Description
alanine aminotransferase (U/L)
Time Frame
6 months after surgery
Title
short-term complications
Description
γ-glutamyl transpeptidase (U/L)
Time Frame
6 months after surgery
Title
short-term complications
Description
Serum Bilirubin (μmol/L)
Time Frame
6 months after surgery
Title
short-term complications
Description
number of participants with postoperative wound infection
Time Frame
1 month after surgery
Title
Long-term complications
Description
number of participants with anastomotic stricture
Time Frame
3 years after surgery
Secondary Outcome Measure Information:
Title
length of stay
Description
length of hospital stay
Time Frame
1 month after surgery
Title
duration of ventilator support
Description
duration of ventilator support
Time Frame
1 month after surgery
Title
length of nutritional support in hospital
Description
length of nutritional support in hospital
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xisi guan
Phone
13926155230
Email
545280987@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst
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