The Follow-up Study for 100000 Adults in 2-Year Hepatocellular Carcinoma (HCC) Screening in Tainan County. Comparisons of the Two 2-Stage Hcc Screening Programs (I), and a Randomized Control Trial of Surveillance Intervals of HCC in High-Risk Group (II)

Tainan County Health Bureau has conducted 「mobilized-hospital and overall health inspection」 for years. A total of 56,702 adults have been screened in 2004 and 43,502 in 2005. Community-based hepatocellular carcinoma (HCC) screen has been included. The HCC screening was a two-staged design. The first stage is identification of high risk subjects by laboratory tests and the second stage is ultrasonography screening on the high risk group. In 2004, 3242 (5.72%) subjects met alpha-fetoprotein (AFP) ＞20 ng/ml and platelet count ＜150 x 103/mm3 and were defined as high risk group. In 2005, 13,934 (32.0%) adults were positive for any of HBsAg, anti-HCV, ALT, AST and AFP and were included in the high risk group. All suspected cases screened from 2nd stage ultrasonography were referred to medical centers for confirmation. However, there were two limitations in the screening program. One was incomplete follow-up for the referred suspected cases, and the other was no further surveillance program on the identified high risk subjects. The current study will be a continuous study of the screening program. This study included two parts: Part I. comparison of the two different HCC screening programs and Part II. a randomized control trial of surveillance intervals of HCC among high risk groups. Part I: There was no previous study comparing the pros and cons between the two screening designs by actual population. We will collect the complete data of referred suspected cases, including their confirmation criteria, staging, treatment and survival and will also obtain official mortality within 3 year after screening. The analyses will focus on the 1. economical considerations, 2.validity, such as sensitivity, specificity and predictive values and 3. allocation of suitable screening program according prevalence of liver diseases. Part II: Using a randomized control trial, we try to elucidate adequate interval of HCC surveillance among high risk group. In 6 high endemic townships, we will recruit residents who have been previous screened and met the criteria of positive for HBsAg or anti-HCV and with platelet count of 150 x 103/mm3 or lower. HCC surveillance by AFP and ultrasonography with an interval of 4 months or one year will be conducted. Three of townships will be randomly assigned to4-month group and the other 3 will be in 1-year group. The study subjects should be followed for at least 3 years. Detected tumor size, confirmation rate, treatment modalities and response, and survival will be analyzed to answer which should be adequate surveillance interval. It should be cost-benefit to study a large screened population. The results of this study will be an adequate community-based screening method of HCC and a adequate surveillance interval of high risk group. The results should upgrade the evidence level of our own data and provide good reference of our evidence-based HCC practice guideline.

Project ID:PC9706-0487
External Project ID:NSC96-2314-B182-021-MY3