Tadatoshi Takayama1, Kiyoshi Hasegawa2, Namiki Izumi3, Masatoshi Kudo4, Mitsuo Shimada5, Naoki Yamanaka6, Masafumi Inomata7, Shuichi Kaneko8, Hisashi Nakayama1, Yoshikuni Kawaguchi2, Kosuke Kashiwabara9, Ryosuke Tateishi10, Shuichiro Shiina11, Kazuhiko Koike10, Yutaka Matsuyama12, Masao Omata13, Masatoshi Makuuchi14, Norihiro Kokudo15. 1. Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan. 2. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan. 3. Department of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan. 4. Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka, Japan. 5. Department of Surgery, Tokushima University School of Medicine, Tokushima, Japan. 6. Meiwa Hospital, Hyogo, Japan. 7. Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine, Oita, Japan. 8. Department of Gastroenterology, Graduate School of Medicine, Kanazawa University, Ishikawa, Japan. 9. Biostatistics Division, Central Coordinating Unit, Clinical Research Support Center, the University of Tokyo Hospital, Tokyo, Japan. 10. Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan. 11. Department of Gastroenterological Imaging and Interventional Oncology, Juntendo University, Tokyo, Japan. 12. Department of Biostatistics, School of Public Health, the University of Tokyo, Tokyo, Japan. 13. Internal Medicine, Yamanashi Prefectural Central Hospital, Yamanashi, Japan. 14. Koto Hospital, Tokyo, Japan. 15. National Center for Global Health and Medicine, Tokyo, Japan.
Abstract
Introduction: It remains unclear which surgery or radiofrequency ablation (RFA) is the more effective treatment for small hepatocellular carcinoma (HCC). We aimed to compare survival between patients undergoing surgery (surgery group) and patients undergoing RFA (RFA group). Methods: We conducted a randomized controlled trial involving 49 institutions in Japan. Patients with Child-Pugh scores ≤7, largest HCC diameter ≤3 cm, and ≤3 HCC nodules were considered eligible. The co-primary endpoints were recurrence-free survival (RFS) and overall survival (OS). The current study reports the final result of RFS, and the follow-up of OS is still ongoing. Results: During 2009-2015, 308 patients were registered. After excluding ineligible patients, the surgery and RFA groups included 150 and 151 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range [IQR], 1.5-2.2 cm) in the surgery group and 1.8 cm (IQR, 1.5-2.3 cm) in the RFA group. The median procedure duration (274 vs. 40 min, p < 0.01) and the median duration of hospital stay (17 days vs. 10 days, p < 0.01) were longer in the surgery group than in the RFA group. RFS did not differ significantly between the groups as the median RFS was 3.5 (95% confidence interval [CI], 2.6-5.1) years in the surgery group and 3.0 (95% CI, 2.4-5.6) years in the RFA group (hazard ratio, 0.92; 95% CI, 0.67-1.25; p = 0.58). Discussion/ Conclusion: Our study did not show which surgery or RFA is the better treatment option for small HCC.
Introduction: It remains unclear which surgery or radiofrequency ablation (RFA) is the more effective treatment for small hepatocellular carcinoma (HCC). We aimed to compare survival between patients undergoing surgery (surgery group) and patients undergoing RFA (RFA group). Methods: We conducted a randomized controlled trial involving 49 institutions in Japan. Patients with Child-Pugh scores ≤7, largest HCC diameter ≤3 cm, and ≤3 HCC nodules were considered eligible. The co-primary endpoints were recurrence-free survival (RFS) and overall survival (OS). The current study reports the final result of RFS, and the follow-up of OS is still ongoing. Results: During 2009-2015, 308 patients were registered. After excluding ineligible patients, the surgery and RFA groups included 150 and 151 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range [IQR], 1.5-2.2 cm) in the surgery group and 1.8 cm (IQR, 1.5-2.3 cm) in the RFA group. The median procedure duration (274 vs. 40 min, p < 0.01) and the median duration of hospital stay (17 days vs. 10 days, p < 0.01) were longer in the surgery group than in the RFA group. RFS did not differ significantly between the groups as the median RFS was 3.5 (95% confidence interval [CI], 2.6-5.1) years in the surgery group and 3.0 (95% CI, 2.4-5.6) years in the RFA group (hazard ratio, 0.92; 95% CI, 0.67-1.25; p = 0.58). Discussion/ Conclusion: Our study did not show which surgery or RFA is the better treatment option for small HCC.
Authors: G E Gerunda; D Neri; R Merenda; F Barbazza; F Zangrandi; F Meduri; M Bisello; M Valmasoni; A Gangemi; A M Faccioli Journal: Liver Transpl Date: 2000-09 Impact factor: 5.799
Authors: S Kubo; S Nishiguchi; K Hirohashi; T Shuto; T Kuroki; S Minamitani; T Ikebe; T Yamamoto; K Wakasa; H Kinoshita Journal: Jpn J Cancer Res Date: 1998-04