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NCT Number: NCT06716762

Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

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.

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Key information

Conditions

Congenital Choledochal Cyst Bile Duct Diseases Biliary Tract Diseases Choledochal Cyst Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Abnormalities Digestive System Diseases Laparoscopic Surgery Neoplasms Open Surgery Pediatric Surgery Surgical Outcomes

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hansung University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Open Surgery

Procedure

Open cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision

Laparoscopic surgery

Procedure

Laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope

Primary outcomes

  1. Surgery Duration

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

    The time required to complete the surgical procedure, from the initial incision to the closure of the surgical site. This is measured in minutes and compared between the open surgery and laparoscopic surgery groups

  2. Postoperative Complications

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

    The occurrence of postoperative complications, specifically bile leakage and intestinal obstruction, in patients undergoing either open or laparoscopic surgery. This is measured as a binary outcome (yes/no) and will be compared between the two groups.

  3. Intraoperative Blood Loss

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

    The total amount of blood lost during the surgical procedure, measured in milliliters (mL). This will be compared between the two surgical groups (open surgery and laparoscopic surgery).

  4. Hospital Stay

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

    The total number of days the patient stays in the hospital post-surgery until discharge. This is compared between the open surgery and laparoscopic surgery groups.

Sponsors and collaborators

Lead sponsor

In-Jin Jang

Other

Collaborators

  • Affiliated Hospital of Guangdong Medical University

Registry information

Official study title

Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study

Important dates

Study start
2010
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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