Congenital Choledochal CystNCT06716762
Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst
An observational study of Congenital Choledochal Cyst and Pediatric Surgery, run by In-Jin Jang at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Congenital Choledochal Cyst, Pediatric Surgery, Surgical Outcomes
- What is being tested?
- Open Surgery and Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2010to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study
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.
- Conditions
- Congenital Choledochal Cyst, Pediatric Surgery, Surgical Outcomes, Open Surgery, Laparoscopic Surgery
- Being tested
- Open Surgery, Laparoscopic Surgery
- Keywords
- Congenital Choledochal Cys, Network Meta-analysis, Robotic-assisted Surgery, Laparoscopic Surgery, Pediatric Surgical Outcomes
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open SurgeryProcedure or surgery
Open cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision
Laparoscopic SurgeryProcedure or surgery
Laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery Group, OSG | 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. Receives: Procedure: Open Surgery | |
| Laparoscopic Surgery Group, LSG | 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. Receives: Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2010
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Choledochal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- In-Jin Jang
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University
- Responsible party
- Sponsor-investigator, In-Jin Jang, Hansung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716762
- Sponsor's protocol ID
- KY20241121
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06716762
- Acronym / sponsor ID
- KY20241121
- Conditions
- Congenital Choledochal Cyst, Pediatric Surgery, Surgical Outcomes, Open Surgery, Laparoscopic Surgery
- Keywords
- Congenital Choledochal Cys, Network Meta-analysis, Robotic-assisted Surgery, Laparoscopic Surgery, Pediatric Surgical Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- In-Jin JangUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Guangdong Medical University
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Surgery Group, OSG | – | Procedure: Open SurgeryThis 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. |
| Laparoscopic Surgery Group, LSG | – | Procedure: Laparoscopic SurgeryThis 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open SurgeryOpen cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision | Procedure or surgery | Open Surgery Group, OSG |
| Laparoscopic SurgeryLaparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope | Procedure or surgery | Laparoscopic Surgery Group, LSG |
Primary outcome
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
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Choledochal Cyst and Pediatric Surgery, run by In-Jin Jang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery Duration (time frame: Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.