Timing of Operation in Children With a Prenatal Diagnosis of Choledochal Cyst (CDCPS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Choledochal Cyst
• Intervention / Treatment: Procedure: laparoscopic-assisted CDC excision and hepaticojejunostomy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xisi guan; Phone Number: 13926155230; Email: 545280987@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Unable to tolerate surgery after birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prenatally diagnosed CDC; All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative complications	number of participants progressed to CDC-related symptoms before operative intervention	pre-intervention
preoperative complications	number of participants with cyst rupture before operative intervention	pre-intervention
preoperative complications	aspartate aminotransferase (U/L)	1 week before surgery
preoperative complications	alanine aminotransferase (U/L)	1 week before surgery
preoperative complications	γ-glutamyl transpeptidase (U/L)	1 week before surgery
preoperative complications	Serum Bilirubin (μmol/L）	1 week before surgery
short-term complications	number of participants with post-operative anastomotic leak	1 weak after surgery
short-term complications	number of participants with postoperative hemorrhage	1 weak after surgery
short-term complications	aspartate aminotransferase (U/L)	1 weak after surgery
short-term complications	alanine aminotransferase (U/L)	1 weak after surgery
short-term complications	γ-glutamyl transpeptidase (U/L)	1 weak after surgery
short-term complications	Serum Bilirubin (μmol/L）	1 weak after surgery
short-term complications	aspartate aminotransferase (U/L)	3 months after surgery
short-term complications	alanine aminotransferase (U/L)	3 months after surgery
short-term complications	γ-glutamyl transpeptidase (U/L)	3 months after surgery
short-term complications	Serum Bilirubin (μmol/L）	3 months after surgery
short-term complications	aspartate aminotransferase (U/L)	6 months after surgery
short-term complications	alanine aminotransferase (U/L)	6 months after surgery
short-term complications	γ-glutamyl transpeptidase (U/L)	6 months after surgery
short-term complications	Serum Bilirubin (μmol/L）	6 months after surgery
short-term complications	number of participants with postoperative wound infection	1 month after surgery
Long-term complications	number of participants with anastomotic stricture	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	length of hospital stay	1 month after surgery
duration of ventilator support	duration of ventilator support	1 month after surgery
length of nutritional support in hospital	length of nutritional support in hospital	1 month after surgery

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): November 15, 2025
• Study Completion (Anticipated): November 15, 2026

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: November 12, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Congenital Abnormalities; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Cysts; Choledochal Cyst
• Other Study ID Numbers: 521123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No