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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Ultrasound examination and Colonoscopy examination

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 Type: Observational
• Enrollment (Actual): 2315

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consisted entirely of outpatients. Patients were offered to perform colonoscopy for CRC screening according to the American College of Gastroenterology recommendations. Based on blood tests and abdomen B ultrasonography, patients without NAFLD were regarded as healthy controls and those with NAFLD constituted the community NAFLD cohort. Patients were included only if they had colonoscopy and conventional inspections (blood routine, liver function test and abdomen B ultrasonography). Among them who with history of colorectal cancers or polyps, other extraintestinal malignancies and contraindications to colonoscopy were excluded. Besides, we excluded patients who had viral hepatitis, cirrhosis, liver cancer or other liver disease.Patients who drank more than 20g alcohol per day were also excluded.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound examination	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.	Up to 10 months
Colonoscopy examination	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.	Up to 10 months
Statistical analysis	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.	Up to 07 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' baseline characteristics	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.	Up to 10 months
Laboratory Assay and Measurement	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.	Up to 10 months

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: 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

Publications and helpful links

General Publications

• Lin XF, Shi KQ, You J, Liu WY, Luo YW, Wu FL, Chen YP, Wong DK, Yuen MF, Zheng MH. Increased risk of colorectal malignant neoplasm in patients with nonalcoholic fatty liver disease: a large study. Mol Biol Rep. 2014 May;41(5):2989-97. doi: 10.1007/s11033-014-3157-y. Epub 2014 Jan 22.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: July 29, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (ESTIMATE): August 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Neoplasms; Colorectal Neoplasms; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: wenzhouMC 001