An observational study in Congenital Choledochal Cyst, Pediatric Surgery and Surgical Outcomes, sponsored by In-Jin Jang. Completed at 1 site in Korea, Republic of. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by In-Jin Jang · Observational
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.
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
This study's enrollment of 72 is below the median of 400 across 14 observational studies indexed under Choledochal Cyst.
Browse Choledochal Cyst studies →This is the only study on the registry with In-Jin Jang as lead sponsor.
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The study population consists of pediatric patients diagnosed with congenital choledochal cyst (CCC) who underwent surgical treatment at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The total number of patients included in this study is 72, with 60 patients assigned to the open surgery group (OSG) and 12 patients assigned to the laparoscopic surgery group (LSG).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group consists of pediatric patients diagnosed with congenital choledochal cyst (CCC) who underwent open surgery, which involved open cyst excision and Roux-en-Y hepaticojejunostomy. A total of 60 patients were assigned to this group.
Procedure: Open Surgery
This group includes pediatric patients diagnosed with CCC who underwent laparoscopic surgery, which involved laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy. A total of 12 patients were assigned to this group.
Procedure: Laparoscopic Surgery
Open cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision
Laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope
Surgery Duration
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
Time frame: Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.
Postoperative 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.
Time frame: 30 days post-surgery (for short-term complications)
Intraoperative Blood Loss
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).
Time frame: Measured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.
Hospital Stay
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.
Time frame: Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.
Plan to share: Undecided
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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