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Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: A Prospective Randomized Controlled Trial
NCT07825935 · Xueqiang Yan · Updated 17 Sept 2026
- What is being tested
- Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management
- For
- Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts; Choledochal Cyst
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 1 Month to 18 years. About 80 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started 1 Sept 2026, ends 28 Feb 2028. Registered 17 Sept 2026.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Wuhan Children'c HospitalWuhan, Hubei, China