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

Colorectal Neoplasms Clinical Trial

— NWC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657773
• Other study ID #: wenzhouMC 001
• Status: Completed
• Phase: N/A
• First received: July 29, 2012
• Last updated: August 3, 2012
• Start date: April 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2315
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease

Intervention

Other:
• Ultrasound examination and Colonoscopy examination

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No