Can some children skip the drain after choledochal cyst surgery?
NCT ID NCT07825935
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Choledochal cyst is a congenital bile duct problem that surgeons treat by removing the cyst and rebuilding the bile duct with a Roux-en-Y hepaticojejunostomy, often using a surgical robot. Surgeons usually leave an abdominal drainage tube in place afterward, but better robot precision raises the question of whether every child needs one. This trial randomly assigns 80 children to either routine drainage or a selective approach, where a preoperative risk model based on cyst size, age, BMI, hemoglobin, and globulin decides who gets a drain. Researchers track serious complications such as bile leaks, bleeding, and infection within 30 and 90 days to compare the two strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a selective drainage strategy guided by a preoperative risk model, compared with routine abdominal drainage after robot-assisted surgery
- What this could lead to
- If it works, children at low risk could avoid an unnecessary drainage tube after surgery, which may mean less discomfort and a simpler recovery.
- What could go wrong
- The trial is small and single-center, so its results may not apply everywhere. Skipping drainage in the wrong child could allow bile leaks or infections to go unnoticed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wuhan Children'c Hospital
Wuhan, Hubei, 430016, China
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