Application of Risk-Stratified Individualized Drainage Strategy in Children With Choledochal Cyst Undergoing Robot-Assisted Roux-en-Y Hepaticojejunostomy: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Severe Complications Within 30 Days Postoperatively
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Arm 1: Experimental Group (Selective Drainage Group) Arm Title (Group Name): Selective Peritoneal Drainage Group or Experimental: Selective Drainage Group
Arm Type (Group Type): Typically selected as Experimental (Experimental)
Description (Description): Based on preoperative predictive models (cyst diameter, BMI, HGB, GLB, etc.), risk probability is calculated, and abdominal drainage tubes are placed only in high-risk children, while low-risk children do not receive drainage tubes.
Arm 2: Control Group (Conventional Drainage Group) Arm Title: Conventional Peritoneal Drainage Group or Active Comparator: Conventional Drainage Group
Arm Type: Select Active Comparator (Active Control) or No Intervention (No Intervention? But here there is conventional drainage, so Active Comparator should be selected)
Description: All children receive conventional abdominal drainage tubes postoperatively.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Selective Drainage Group
Patients with low-risk prediction (<85%) do not receive abdominal drainage; patients with high-risk prediction (≥85%) receive drainage tube placement.
干预措施: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management (Procedure)
Conventional Drainage Group
All patients receive routine abdominal drainage tube placement postoperatively.
干预措施: Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management (Procedure)
结局指标
主要结局
Incidence of Severe Complications Within 30 Days Postoperatively
时间窗: 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
时间窗: Postoperative 90 days
Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy.
次要结局
未报告次要终点
研究者
Xueqiang Yan
Principal Investigator
Wuhan Children's Hospital