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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01657773
Acronym
NWC
Enrollment
2315
Registered
2012-08-06
Start date
2012-04-30
Completion date
2012-07-31
Last updated
2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms, Nonalcoholic Fatty Liver Disease

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.

Interventions

OTHERUltrasound examination and Colonoscopy examination

Sponsors

Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound examinationUp to 10 monthsHepatic 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 examinationUp to 10 monthsBefore 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 analysisUp to 07 monthsThe 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

MeasureTime frameDescription
Patients' baseline characteristicsUp to 10 monthsPatients' 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 MeasurementUp to 10 monthsComplete 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026