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NCT Number: NCT07825935

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.

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Key information

Conditions

Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts Bile Duct Diseases Biliary Tract Diseases Choledochal Cyst Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Digestive System Abnormalities Digestive System Diseases Neoplasms

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xueqiang Yan, Doctor

CONTACT

[email protected]

+8615871716704

Sponsors and collaborators

Lead sponsor

Xueqiang Yan

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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