CompletedNot Applicable

Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

South Korea72 participantsStarted 2010-01-01

Plain-language summary

This is a retrospective cohort study designed to compare the outcomes of open surgery versus laparoscopic surgery in pediatric patients diagnosed with congenital choledochal cyst (CCC). The study includes children who underwent surgery at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The aim of this study is to evaluate and compare the surgical outcomes, including surgery duration, intraoperative blood loss, hospital stay, and postoperative complications (e.g., bile leakage and intestinal obstruction), between the two surgical approaches. The data collected from the patient records will be analyzed to identify factors influencing surgical outcomes and to guide future treatment decisions for CCC in pediatric patients.

Who can participate

Age range

0 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Pediatric patients diagnosed with congenital choledochal cyst based on preoperative imaging (e.g., ultrasound, computed tomography（CT）, or magnetic resonance cholangiopancreatography（MRCP)）. Patients who underwent either open surgery (open cyst excision and Roux-en-Y hepaticojejunostomy) or laparoscopic surgery (laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy) for the treatment of congenital choledochal cyst. Informed consent for follow-up obtained from the patient's family or legal guardian. Exclusion Criteria: Patients lacking one or more key outcome measures, including surgery duration, hospital stay, intraoperative blood loss, incidence of postoperative bile leakage, or incidence of postoperative intestinal obstruction. Patients with incomplete clinical data, such as missing sex, age, or other essential demographic information. Patients with coagulation disorders that may interfere with surgery or recovery. Patients with severe comorbidities or immune system disorders that may complicate surgical intervention or recovery. Patients who underwent non-surgical treatment (e.g., endoscopic procedures) for congenital choledochal cyst. Pregnant patients or those who are breastfeeding (if applicable to your study population).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Surgery Duration

Timeframe: Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.

Postoperative Complications

Timeframe: 30 days post-surgery (for short-term complications)

Intraoperative Blood Loss

Timeframe: Measured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.

Hospital Stay

Timeframe: Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.

Trial details

NCT IDNCT06716762

SponsorIn-Jin Jang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Congenital Choledochal Cyst trials