Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: 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.

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