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临床试验/NCT04410848
NCT04410848Unknown不适用

Symbolic Regression Model To Predict Choledocholithiasis: Prospective Validation

Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年6月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
To validate prospectively a symbolic regression model to predict choledocholithiasis

研究概览

简要总结

Choledocholithiasis refers to the presence of gallstones within the common bile duct. It is proposed to look for markers that help in the diagnosis and in differentiating between retained and migrated gallstones. The selection of patients is a very important aspect, due to the economic aspects and possible complications. Taking advantage of the development of technology, the improvement in computer systems, the use of artificial intelligence and a symbolic regression model that works to predict the presence of choledocholithiasis and provide evidence that clarifies the treatment of patients with this pathology, especially in this group where there is a bigger controversy.

详细描述

Choledocholithiasis refers to the presence of gallstones within the common bile duct. It is proposed to look for markers that help in the diagnosis and in differentiating between retained and migrated gallstones. The selection of patients to perform endoscopic retrograde cholangiopancreatography (ERCP) is a very important aspect, due to the economic aspects and possible complications. By making a proper patient selection for additional studies or procedure, then the costs, complications and days of stay would be reduced. Avoiding the unnecessary use of ERCP would avoid its complications. Taking advantage of the development of technology, the improvement in computer systems, the use of artificial intelligence and a Symbolic Regression Model that works to predict the presence of choledocholithiasis and provide evidence that clarifies the treatment of patients with this pathology, especially in this group where there is a bigger controversy.

Having the historical database of the University Hospital (HU), regarding clinical, laboratory and image variables of patients with suspected choledocholithiasis, using a symbolic regression method, several randomly formed equations are generated. Each equation deducts its coefficient of linear correlation (Pearson's correlation).

For the following study we admitted to the emergency department of adults at the University Hospital all patients with clinical suspicion of choledocholithiasis, who meet the inclusion criterion. The study which is realized is a normal one based on the method of clinical predictors, obtaining laboratory studies, image studies, and patient management will be carried out based on the method of clinical predictors. The calculation is made with the equation obtained, and the patient is monitored until discharge. The calculation obtained from the equation will not be taken into account for the decisions in the management of the patient. The variables studied as white blood cells, total bilirubin values, direct bilirubin, indirect bilirubin, Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST), alkaline phosphatase (AP), gamma-glutamyl transpeptidase (GGT) at admission will be taken from the clinical record. Transabdominal ultrasonography will be performed upon admission by the diagnostic radiology department of the HU and the size of the bile duct in mm, presence of gallbladder gallstones and bile duct stones will be taken from the report. ERCP, magnetic resonance cholangiopancreatography (MRCP) or intraoperative cholangiography will be performed and one will be taken as a confirmation of choledocolithiasis, and its absence would rule it out.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above 18 with clinical suspicion of choledocholithiasis by biliary-type pain, laboratory testing that reveals a cholestatic pattern of liver test abnormalities, biliary pancreatitis or dilated common bile duct

排除标准

  • Patient with a history of cholecystectomy
  • History of previous ERCP or surgery involving bile duct
  • Patient who could not be followed
  • Patient with other pathology that causes alteration of liver function test.

结局指标

主要结局

To validate prospectively a symbolic regression model to predict choledocholithiasis

时间窗: 72 horas

To validate a model to predict choledocholithiasis compared clinical predictors.

次要结局

未报告次要终点

研究者

发起方
Hospital Universitario Dr. Jose E. Gonzalez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Hector Eloy Tamez Perez

Clinical Professor

Hospital Universitario Dr. Jose E. Gonzalez

研究点 (1)

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