Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm

Completed

• Conditions: Colorectal Neoplasms; Nonalcoholic Fatty Liver Disease
• Interventions: Other: Ultrasound examination and Colonoscopy examination

• Registration Number: NCT01657773
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Study First Submitted: 2012-07-29
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-03
• Last Update Submitted: 2012-08-03
• Study First Posted: 2012-08-06
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2315

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
colorectal cancer, without nonalcoholic fatty liver disease	Ultrasound examination and Colonoscopy examination	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.
colorectal cancer, with nonalcoholic fatty liver disease	Ultrasound examination and Colonoscopy examination	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.

Primary Outcome Measures

Name	Time	Method
Ultrasound examination	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Patients' baseline characteristics	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	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.

Trial Locations

Locations (1)

Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China