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临床试验/NCT01657773
NCT01657773已完成不适用

Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.

Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 2,315 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,315
试验地点
1
主要终点
Ultrasound examination

研究概览

简要总结

The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for CRC.

详细描述

As one of the most common cancer worldwide, colorectal cancer (CRC) is a major cause of cancer death in Asian countries. And during the past three decades, the incidence of CRC has been increasing rapidly in china. Many studies supported that cigarette smoking, obesity and insulin resistance were associated with CRC. In recent years, metabolic syndrome (MetS) - Including glucose tolerance, dyslipidemia, obesity, hypertension and chronic inflammation - and its individual components have been proven to be the risk for colorectal neoplasm. Colonoscopy is the most accurate technique for diagnosis, surveillance and exclusion of colorectal neoplasm for high-risk CRC groups. Therefore, improved risk stratification knowledge of the target population is necessary to improve CRC patients' prognosis.

Nonalcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and cause a wide spectrum of liver damage, such as steatohepatitis, cirrhosis, even end-stage liver disease and hepatocellular carcinoma. NAFLD has been found to be associated with obesity, insulin resistance, hypertension and dyslipidemia, and is considered as a liver manifestation of MetS. Although it has been also well established that MetS and its individual components are risk factors for colorectal neoplasm, as above, there is paucity of research looking at the relation between NAFLD and CRC. Therefore, the investigators aimed to investigate the prevalence of CRC in patients with NAFLD and evaluate whether NAFLD is an independent risk factor for CRC.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients had colonoscopy and
  • Patients had conventional inspections(blood routine, liver function test and abdomen B ultrasonography)

排除标准

  • Patients were excluded with history of colorectal cancers or polyps, other extraintestinal malignancies and contraindications to colonoscopy.
  • Patients were excluded who had viral hepatitis, cirrhosis, liver cancer or other liver disease.
  • Patients ere excluded who drank more than 20g alcohol per day.

结局指标

主要结局

Ultrasound examination

时间窗: Up to 10 months

Hepatic ultrasonography scanning was performed on all patients by experienced radiologists who were blinded to the aims of the study and clinical details of the patients. NAFLD was diagnosed by the following criterion: hepatomegaly, the echogenicity of liver parenchyma increased diffusely, and vascular blurring.

Colonoscopy examination

时间窗: Up to 10 months

Before performed colonoscopy examination, all patients were given 4L polyethelyne glycol lavage solution for bowel preparation. The colonoscopic features include the types, location, size, number of lesions and differentiation of neoplasm.

Statistical analysis

时间窗: Up to 07 months

The Binary logistic regression analysis was applied to assay the correlation between NAFLD and CRC after adjustment for independent factors, including age, gender, smoking, and family history.

次要结局

  • Patients' baseline characteristics(Up to 10 months)
  • Laboratory Assay and Measurement(Up to 10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming-Hua Zheng

Attending physician

Wenzhou Medical University

研究点 (1)

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