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1115 Risk factors for hepatocellular carcinoma in hepatitis B surface antigen positive carriers
HEPATOLOGY, Vol. 38, No. 4, Suppl. 1, 2003
AASLD ABSTRACTS
1115 RISK FACTORS FOR HEPATOCELLULAR CARCINOMA IN HEPATITIS B SURFACE ANTIGEN POSITIVE CARRIERS.
Chang Mo Moon, Kwang-Hyub Han, Ki Jun Song, Sang Hoon Ahn, Jong Won Choi, Yong Han Paik, Dong Kee Kim, Sung Min Myung, Chae Yoon Chon, Young Myoung Moon, Yonsei University College of Medicine, Seoul, South Korea Backgrounds/Aims : Korea is hyperendemic area of hepatitis B virus (HBV) infection by which most hepatocelluar carcinoma (HCC)(over 70%) have b e e n developed. Since HBV infection is most common cause for HCC in Korea, we have analyzed risk factors for HCC confined to hepatitis B surface antigen (HBsAg)positive carriers. Patients and Methods : Between Jan. 1990 and Dec. 2000, a total of 688 chronic HBsAg-positive carriers without liver cirrhosis who had participated in the screening program for HCC were prospectively enrolled. Because liver cirrhosis was very strong risk factor for HCC regardless of HBV infection (Hepatology 2002;36(abstr): 302A), we limited subjects to inactive carrier and chronic hepatitis excluding liver cirrhosis. This inclusion criteria may represent risk factors under the condition of HBV infection. The risk factors for development of HCC were evaluated by self-exploited data base system. Chi-sq uare test and logistic regressing analysis were used by SAS program. Results : Forty six patients out of 688 patients had developed HCC during the follow-up (mean 50 months). The mean age of patients with HCC was 53.04 yrs. The mean size of HCC at diagnosis is 2.5cm. The i n d e p e n d e n t risk factors by univariate analysis (p<0.05) were old age (over 40 yrs old), male patients, initial level of serum AFP (>20ng/mL), platelet count (<150,000/uL), serum albumin (<3.5g/dL) at enrollment, severe liver parenchymal echogenic pattern in ultrasonography and heavy alcoholics. Multivariate analysis showed age (over 40 yrs old, p-0.009), male (p-0.011), AFP (>20ng/mL, p-0.011), severe liver parenchymal echogenic pattern in ultrasonography (p-0.0002) and heavy alcoholics (p-0.0428) to be significant risk factors for HCC. We also found that the more risk factors, the higher HCC development. Conclusions : We demonstrated the high risk factors in chronic HBsAg positive carriers without liver cirrhosis. According to the risk factors, the new individual prediction model for screening of HCC in this group is in the pipeline. Disclosures: Sang Hoon Ahn - No relationships to disclose Jong Won Choi No relationships to disclose Chae Yoon Chon - No relationships to disclose Kwang-Hyub H a n - No relationships to disclose Dong Kee Kim - No relationships to disclose Chang Mo Moon - No relationships to disclose Young Myoung Moon - No relationships to disclose Sung Min Myung - No relationships to disclose Yong Han Paik - No relationships to disclose Ki Jun Song No relationships to disclose -
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693A
1116 INFORMED CONSENT AND CLINICAL TRIALS FOR CHRONIC HEPATITIS B IN ASIA: DO PATIENTS UNDERSTAND THE CONCEPTS? Belinda Mak, Chun-Tao Wai,
Mei-Hua Chen, Seng-Gee Lim, National University Hospital, Singapore, Singapore IntroductionMany clinical trials are currently being performed in Asia. As part of Good Clinical Practice, informed consent is mandatory. However, an understanding of the informed consent process and the concept of the randomized controlled trials have not been assessed in Asia. Potential difficulties include a language barrier and different cultural backgrounds. Aim We set to determine patient's understanding of the informed consent processL and basic concepts behind randomized controlled clinical trials in Asian patients with chronic hepatitis B. Methods Forty-two Chinese patients with chronic hepatitis B from 7 therapeutic randomized controlled clinical trials on nucleotide analogues were randomly asked to participate in this interview study. All subjects had given informed consent to a randomized controlled clinical trial at an earlier date. All were interviewed on a 10-item questionnaire, which included questions on the meaning of informed consent, randomized trial, placebo, as well as reason for their participation in the clinical trials. To avoid bias during the interview, the interview was conducted by one assigned administrative assistant, who had not b e e n involved in any clinical trial or informed consent process. Data were expressed in mean -+S.D. unless otherwise stated. Results Age of subjects was 39_+11 (range 21-58) years, 36 (86%) were male. On a visual analogue scale of 1(minimum) to 5 (maximum), scores for comprehensiveness and complexity of the consent form was 3.7_+0.8 and 2.6_+0.9, respectively, and score for their understanding of the informed consent which the subjects had signed previously was 3.9_+0.8. On the specific aspects of clinical trials, only 13 (31%) subjects thought their trials were randomized, 27 (64%) were unsure and 2 (5%) thought the trials were non-randomized. On the meaning of placebo, only15 (36%) knew placebo was a non-active drugs. Regarding follow up procedures of clinical trials, 7 (17%) did not know regular follow visits were necessary, 11 (26%) did not know they should report any new symptoms as potential adverse effects, and 11 (26%) thought their medical care might change if they withdrew from the study. Forty-one (98%) felt benefited from the trials: 37 (88%) felt they had better medical attention, 28 (67%) felt benefited from the new drug, and 26 (62%) felt benefited from the free treatment and blood tests. Conclusion Despite the fact that all subjects in this study gave an earlier informed consent for the respective clinical trials, many had an incorrect idea and impression about the meaning of placebo, randomization, and the follow up procedures of a clinical trial. Further education and streamlining of the informed consent process may be n e e d e d for patients from Asia. Disclosures: Mei-Hua C h e n - No relationships to disclose Seng-Gee Lim - No relationships to disclose Belinda Mak - No relationships to disclose Chun-Tao Wai - No relationships to disclose
AASLD ABSTRACTS
1115 RISK FACTORS FOR HEPATOCELLULAR CARCINOMA IN HEPATITIS B SURFACE ANTIGEN POSITIVE CARRIERS.
Chang Mo Moon, Kwang-Hyub Han, Ki Jun Song, Sang Hoon Ahn, Jong Won Choi, Yong Han Paik, Dong Kee Kim, Sung Min Myung, Chae Yoon Chon, Young Myoung Moon, Yonsei University College of Medicine, Seoul, South Korea Backgrounds/Aims : Korea is hyperendemic area of hepatitis B virus (HBV) infection by which most hepatocelluar carcinoma (HCC)(over 70%) have b e e n developed. Since HBV infection is most common cause for HCC in Korea, we have analyzed risk factors for HCC confined to hepatitis B surface antigen (HBsAg)positive carriers. Patients and Methods : Between Jan. 1990 and Dec. 2000, a total of 688 chronic HBsAg-positive carriers without liver cirrhosis who had participated in the screening program for HCC were prospectively enrolled. Because liver cirrhosis was very strong risk factor for HCC regardless of HBV infection (Hepatology 2002;36(abstr): 302A), we limited subjects to inactive carrier and chronic hepatitis excluding liver cirrhosis. This inclusion criteria may represent risk factors under the condition of HBV infection. The risk factors for development of HCC were evaluated by self-exploited data base system. Chi-sq uare test and logistic regressing analysis were used by SAS program. Results : Forty six patients out of 688 patients had developed HCC during the follow-up (mean 50 months). The mean age of patients with HCC was 53.04 yrs. The mean size of HCC at diagnosis is 2.5cm. The i n d e p e n d e n t risk factors by univariate analysis (p<0.05) were old age (over 40 yrs old), male patients, initial level of serum AFP (>20ng/mL), platelet count (<150,000/uL), serum albumin (<3.5g/dL) at enrollment, severe liver parenchymal echogenic pattern in ultrasonography and heavy alcoholics. Multivariate analysis showed age (over 40 yrs old, p-0.009), male (p-0.011), AFP (>20ng/mL, p-0.011), severe liver parenchymal echogenic pattern in ultrasonography (p-0.0002) and heavy alcoholics (p-0.0428) to be significant risk factors for HCC. We also found that the more risk factors, the higher HCC development. Conclusions : We demonstrated the high risk factors in chronic HBsAg positive carriers without liver cirrhosis. According to the risk factors, the new individual prediction model for screening of HCC in this group is in the pipeline. Disclosures: Sang Hoon Ahn - No relationships to disclose Jong Won Choi No relationships to disclose Chae Yoon Chon - No relationships to disclose Kwang-Hyub H a n - No relationships to disclose Dong Kee Kim - No relationships to disclose Chang Mo Moon - No relationships to disclose Young Myoung Moon - No relationships to disclose Sung Min Myung - No relationships to disclose Yong Han Paik - No relationships to disclose Ki Jun Song No relationships to disclose -
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693A
1116 INFORMED CONSENT AND CLINICAL TRIALS FOR CHRONIC HEPATITIS B IN ASIA: DO PATIENTS UNDERSTAND THE CONCEPTS? Belinda Mak, Chun-Tao Wai,
Mei-Hua Chen, Seng-Gee Lim, National University Hospital, Singapore, Singapore IntroductionMany clinical trials are currently being performed in Asia. As part of Good Clinical Practice, informed consent is mandatory. However, an understanding of the informed consent process and the concept of the randomized controlled trials have not been assessed in Asia. Potential difficulties include a language barrier and different cultural backgrounds. Aim We set to determine patient's understanding of the informed consent processL and basic concepts behind randomized controlled clinical trials in Asian patients with chronic hepatitis B. Methods Forty-two Chinese patients with chronic hepatitis B from 7 therapeutic randomized controlled clinical trials on nucleotide analogues were randomly asked to participate in this interview study. All subjects had given informed consent to a randomized controlled clinical trial at an earlier date. All were interviewed on a 10-item questionnaire, which included questions on the meaning of informed consent, randomized trial, placebo, as well as reason for their participation in the clinical trials. To avoid bias during the interview, the interview was conducted by one assigned administrative assistant, who had not b e e n involved in any clinical trial or informed consent process. Data were expressed in mean -+S.D. unless otherwise stated. Results Age of subjects was 39_+11 (range 21-58) years, 36 (86%) were male. On a visual analogue scale of 1(minimum) to 5 (maximum), scores for comprehensiveness and complexity of the consent form was 3.7_+0.8 and 2.6_+0.9, respectively, and score for their understanding of the informed consent which the subjects had signed previously was 3.9_+0.8. On the specific aspects of clinical trials, only 13 (31%) subjects thought their trials were randomized, 27 (64%) were unsure and 2 (5%) thought the trials were non-randomized. On the meaning of placebo, only15 (36%) knew placebo was a non-active drugs. Regarding follow up procedures of clinical trials, 7 (17%) did not know regular follow visits were necessary, 11 (26%) did not know they should report any new symptoms as potential adverse effects, and 11 (26%) thought their medical care might change if they withdrew from the study. Forty-one (98%) felt benefited from the trials: 37 (88%) felt they had better medical attention, 28 (67%) felt benefited from the new drug, and 26 (62%) felt benefited from the free treatment and blood tests. Conclusion Despite the fact that all subjects in this study gave an earlier informed consent for the respective clinical trials, many had an incorrect idea and impression about the meaning of placebo, randomization, and the follow up procedures of a clinical trial. Further education and streamlining of the informed consent process may be n e e d e d for patients from Asia. Disclosures: Mei-Hua C h e n - No relationships to disclose Seng-Gee Lim - No relationships to disclose Belinda Mak - No relationships to disclose Chun-Tao Wai - No relationships to disclose