Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm (NWC)
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|ClinicalTrials.gov Identifier: NCT01657773|
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
|Condition or disease||Intervention/treatment|
|Colorectal Neoplasms Nonalcoholic Fatty Liver Disease||Other: Ultrasound examination and Colonoscopy examination|
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.
|Study Type :||Observational|
|Actual Enrollment :||2315 participants|
|Observational Model:||Case Control|
|Official Title:||Study of the Prevalence of Colorectal Cancer in Patients With Nonalcoholic Fatty Liver Disease.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||July 2012|
U.S. FDA Resources
colorectal cancer, without nonalcoholic fatty liver disease
Patients were performed colonoscopy examination for colorectal cancer and who had been foud colorectal cancer proven by biopsy.Then the colorectal cancer patients who had not been diagnosed with nonalcoholic fatty liver disease was based on blood tests and abdomen ultrasound examination.
|Other: Ultrasound examination and Colonoscopy examination|
colorectal cancer, with nonalcoholic fatty liver disease
Patients were performed colonoscopy examination for colorectal cancer and who had been foud colorectal cancer proven by biopsy.Then the colorectal cancer patients who had been diagnosed with nonalcoholic fatty liver disease was based on blood tests and abdomen ultrasound examination ultrasonography.
|Other: Ultrasound examination and Colonoscopy examination|
- Ultrasound examination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Patients' baseline characteristics [ Time Frame: Up to 10 months ]Patients' baseline characteristics were collected before colonoscopy examination. Smoking, alcohol consumption, past medical history, and family history were all recorded using a standardized questionnaire.Blood pressure (BP) was measured in rest state with a standard mercury sphygmomanometer.
- Laboratory Assay and Measurement [ Time Frame: Up to 10 months ]Complete blood count, liver function, blood glucose , blood lipids, Cancer Embryo Antigen (CEA) and other related test were performed when underwent colonoscopy examination. The liver function test included alanine aminotranferase, aspartate aminotranferase, albumin, serum sodium, serum chloride, serum chloride and creatinine. Complete blood count was made up of platelet and hemoglobin (Hb). Blood lipids test contains, total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides. Additionally, CEA was detected by conventional serological assays.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657773
|Wenzhou Medical College|
|Wenzhou, Zhejiang, China, 325000|
|Study Chair:||MingHua Zheng, Medical Master||First Affiliated Hospital of Wenzhou Medical College|
|Principal Investigator:||XianFeng Lin, Medical undergraduate||Wenzhou Medical University|
|Principal Investigator:||KeQing Shi, Medical Master||First Affiliated Hospital of Wenzhou Medical College|
|Principal Investigator:||WenYue Liu, Medical undergraduate||First Affiliated Hospital of Wenzhou Medical College|