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

NCT ID: NCT05620485

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2026-11-15

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.

Conditions

Choledochal Cyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prenatally diagnosed CDC

All patients received laparoscopic-assisted CDC excision and hepaticojejunostomy.

Group Type: EXPERIMENTAL

laparoscopic-assisted CDC excision and hepaticojejunostomy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Xisi Guan

Clinical attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

xisi guan

Role: CONTACT

545280987@qq.com

13926155230

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

521123

Identifier Type: -

Identifier Source: org_study_id