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NCT Number: NCT01657773

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

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Fatty Liver Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Neoplasms Neoplasms by Site Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Rectal Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound examination and Colonoscopy examination

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

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

Acronym: NWC

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2012
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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