Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal CystsNCT07825935
Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: A Prospective Randomized Controlled Trial
A study testing Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management in people with Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts and Choledochal Cyst, run by Xueqiang Yan at 1 site in China.
Trial summary
Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts, Choledochal Cyst
- What is being tested?
- Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: Age 0-18 years, with clinical and imaging diagnosis of choledochal cyst (Todani type I or IV)；Scheduled to undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy；Complete preoperative data available: cyst diameter, BMI, hemoglobin (HGB), globulin (GLB)；Preoperative predictive model applicable for risk probability calculation；Guardian provides signed informed consent Exclusion Criteria: Complex congenital biliary malformations or other severe congenital anomalies; Previous abdominal surgery history; Pre-existing severe coagulation disorders or active infection; Severe cardiac, pulmonary, hepatic, or renal insufficiency (ASA grade ≥IV); Cyst malignancy or suspected malignancy; Emergency surgery (e.g., cyst perforation, acute suppurative cholangitis); Guardian refuses participation or unable to comply with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Wuhan Children'c Hospital
Wuhan, Hubei, 430016
Hao Zheng, +8602782438516, wch_irb@126.com
About this study
Official title: Application of Risk-Stratified Individualized Drainage Strategy in Children With Choledochal Cyst Undergoing Robot-Assisted Roux-en-Y Hepaticojejunostomy: A Prospective Randomized Controlled Trial
Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. With the improved precision of robot-assisted surgery, the necessity of routine drainage has been questioned. This prospective randomized controlled trial aims to evaluate whether a selective drainage strategy based on a preoperative predictive model (using cyst diameter, age, BMI, hemoglobin, and globulin) is safe and effective compared with conventional routine drainage in children undergoing robot-assisted Roux-en-Y hepaticojejunostomy. The primary outcome is the incidence of Clavien-Dindo grade ≥III complications within 30 days postoperatively.
- Conditions
- Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts, Choledochal Cyst
- Being tested
- Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage ManagementProcedure or surgery
All enrolled children undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy. The intervention differentiates in postoperative drainage management: the Selective Drainage Group receives abdominal drainage only when preoperative risk probability is ≥85%, while the Conventional Drainage Group receives routine drainage for all patients.
| Study group | Role | What they receive |
|---|---|---|
| Selective Drainage Group | Experimental | Patients with low-risk prediction (<85%) do not receive abdominal drainage; patients with high-risk prediction (≥85%) receive drainage tube placement. Receives: Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management |
| Conventional Drainage Group | Active comparator | All patients receive routine abdominal drainage tube placement postoperatively. Receives: Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Complications Within 30 Days Postoperatively
Incidence of Clavien-Dindo grade ≥III complications within 30 days after robot-assisted Roux-en-Y hepaticojejunostomy, including bile leakage, pancreatic leakage, intra-abdominal hemorrhage, intra-abdominal infection, wound infection, anastomotic stenosis, reoperation, and mortality.
Measured: 30 days after surgery
Incidence of Severe Complications Within 90 Days Postoperatively
Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy.
Measured: Postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal CystsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xueqiang Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xueqiang Yan, Wuhan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825935
- Sponsor's protocol ID
- 2026R085-F01
- Other IDs
- 2025FEYJS005
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Risk-Stratified Individualized Drainage Strategy in Children With Choledochal Cyst Undergoing Robot-Assisted Roux-en-Y Hepaticojejunostomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07825935
- Acronym / sponsor ID
- 2026R085-F01
- Conditions
- Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts, Choledochal Cyst
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xueqiang YanUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 17 Sep 2026 (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.
Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. With the improved precision of robot-assisted surgery, the necessity of routine drainage has been questioned. This prospective randomized controlled trial aims to evaluate whether a selective drainage strategy based on a preoperative predictive model (using cyst diameter, age, BMI, hemoglobin, and globulin) is safe and effective compared with conventional routine drainage in children undergoing robot-assisted Roux-en-Y hepaticojejunostomy. The primary outcome is the incidence of Clavien-Dindo grade ≥III complications within 30 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Drainage Group | Experimental | Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage ManagementPatients with low-risk prediction (<85%) do not receive abdominal drainage; patients with high-risk prediction (≥85%) receive drainage tube placement. |
| Conventional Drainage Group | Active comparator | Procedure: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage ManagementAll patients receive routine abdominal drainage tube placement postoperatively. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage ManagementAll enrolled children undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy. The intervention differentiates in postoperative drainage management: the Selective Drainage Group receives abdominal drainage only when preoperative risk probability is ≥85%, while the Conventional Drainage Group receives routine drainage for all patients. | Procedure or surgery | Conventional Drainage Group, Selective Drainage Group |
Primary outcome
Incidence of Severe Complications Within 30 Days Postoperatively
Time frame: 30 days after surgery
Incidence of Clavien-Dindo grade ≥III complications within 30 days after robot-assisted Roux-en-Y hepaticojejunostomy, including bile leakage, pancreatic leakage, intra-abdominal hemorrhage, intra-abdominal infection, wound infection, anastomotic stenosis, reoperation, and mortality.
Incidence of Severe Complications Within 90 Days Postoperatively
Time frame: Postoperative 90 days
Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management in people with Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts and Choledochal Cyst, run by Xueqiang Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 17 Sep 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqiang Yan, Doctor (+8615871716704, yanxueqiang1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Complications Within 30 Days Postoperatively (time frame: 30 days after surgery). The study lists 2 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 17 Sep 2026.