search
Back to results

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
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledochal Cyst

Eligibility Criteria

0 Months - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2022
    Last Updated
    November 12, 2022
    Sponsor
    Guangzhou Women and Children's Medical Center
    search

    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

    We'll reach out to this number within 24 hrs