The RCT Study of Two Surgical Biliary-enteric Reconstruction Minimally Invasive Treatment of Bile Duct Dilatation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- operation time
研究概览
简要总结
To observe and compare the short-term and long-term effects of different biliary and intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile duct .
详细描述
The purpose of the study： length of operation time, postoperative intestinal function recovery time as the main index, application prospective clinical study to observe the differences were followed by two different laparoscopic biliary intestinal kiss the short-term and long-term effect of the treatment of congenital cystic dilatation of the bile duct, provide a higher level of evidence based medicine dilatation of patients for congenital bile duct cysts. The choice of second is based on the study, effective, objective evaluation of different laparoscopic biliary enteric reconstruction for the treatment of congenital cystic dilatation of the bile duct is feasible, clear surgical indications, contraindications and summarized the technical points, establish guidelines for clinical diagnosis and treatment of congenital cystic dilation of the bile duct disease.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gender, age 5-70 years old (the disease can occur at any age, but in 80% cases of childhood onset, such as children's height and weight of endoscopic treatment for the standard, by parents as guardians into the group);
- •preoperative congenital cystic dilatation of the bile duct (I, II, IV) clear diagnosis; preoperative assessment of liver function
- •: Child-Pugh = B;
- •bile duct without canceration;
- •recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation;
- •the treatment of choledochal cyst, without any surgical treatment;
- •the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation;
- •voluntarily participated in the study, informed consent.
排除标准
- •congenital cystic dilatation of the bile duct of III type, V type (III type feasible endoscope end of bile duct duodenal sphincterotomy, V type partial resection of the liver);
- •patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery;
- •bad general condition or heart pulmonary dysfunction cannot tolerate surgery;
- •severe cholestatic cirrhosis, severe portal hypertension;
- •high risk patients with general anesthesia.
研究组 & 干预措施
improved Warren-type style
Minimally invasive treatment improved Warren-type cholangiocarcinoma reconstruction is easy
干预措施: improved Warren-type style (Procedure)
Roux-en-Y style
Early open cholecystectomy reconstruction surgery using Roux-en-Y style
干预措施: Roux-en-Y style (Procedure)
结局指标
主要结局
operation time
时间窗: 2 years
Two surgical methods operation time
次要结局
未报告次要终点
研究者
Shuguo Zheng, MD
Professor
Southwest Hospital, China