PMID- 38123994 OWN - NLM STAT- MEDLINE DCOM- 20240311 LR - 20240313 IS - 1468-3288 (Electronic) IS - 0017-5749 (Linking) VI - 73 IP - 4 DP - 2024 Mar 7 TI - Endoscopic variceal ligation versus propranolol for the primary prevention of oesophageal variceal bleeding in patients with hepatocellular carcinoma: an open-label, two-centre, randomised controlled trial. PG - 682-690 LID - 10.1136/gutjnl-2023-330419 [doi] AB - OBJECTIVE: This randomised trial aimed to address whether endoscopic variceal ligation (EVL) or propranolol (PPL) is more effective at preventing initial oesophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC). DESIGN: Patients with HCC and medium-to-large oesophageal varices (EVs) but without previous EVB were randomised to receive EVL (every 3-4 weeks until variceal eradication) or PPL (up to 320 mg daily) at a 1:1 ratio. Long-term follow-up data on EVB, other upper gastrointestinal bleeding (UGIB), non-bleeding liver decompensation, overall survival (OS) and adverse events (AEs) were analysed using competing risk regression. RESULTS: Between June 2011 and April 2021, 144 patients were randomised to receive EVL (n=72) or PPL (n=72). In the EVL group, 7 patients experienced EVB, and 30 died; in the PPL group, 19 patients had EVB, and 40 died. The EVL group had a lower cumulative incidence of EVB (Gray's test, p=0.009) than its counterpart, with no mortality difference (Gray's test, p=0.085). For patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B, EVL was better than PPL in reducing EVB (p<0.001) and mortality (p=0.003). For patients beyond BCLC stage B, between-group outcomes were similar. Other UGIB, non-bleeding liver decompensation and AEs did not differ between groups. A competing risk regression model confirmed the prognostic value of EVL. CONCLUSION: EVL is superior to PPL in preventing initial EVB in patients with HCC. The benefits of EVL on EVB and OS may be limited to patients with BCLC stage A/B and not to those with BCLC stage C/D. TRIAL REGISTRATION NUMBER: NCT01970748. CI - (c) Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Yang, Tsung-Chieh AU - Yang TC AUID- ORCID: 0000-0002-5144-2066 AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Chen, Wen-Chi AU - Chen WC AUID- ORCID: 0000-0002-7572-4201 AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Division of Gastroenterology and Hepatology, Department of Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. AD - Department of Post-Baccalaureate Medicine, National Sun Yat-sen University, Kaohsiung, Taiwan. FAU - Hou, Ming-Chih AU - Hou MC AUID- ORCID: 0000-0002-4886-0718 AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan mchou@vghtpe.gov.tw. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Chen, Ping-Hsien AU - Chen PH AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan. AD - Division of Gastroenterology and Hepatology, Department of Medicine, West Garden Hospital, Taipei, Taiwan. FAU - Lee, Pei-Chang AU - Lee PC AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Chang, Chung-Yu AU - Chang CY AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. AD - Healthcare and Services Center, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Lu, Hsiao-Sheng AU - Lu HS AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Chen, Yu-Jen AU - Chen YJ AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Hsu, Shao-Jung AU - Hsu SJ AUID- ORCID: 0000-0003-4884-634X AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Huang, Hui-Chun AU - Huang HC AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. FAU - Luo, Jiing-Chyuan AU - Luo JC AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. FAU - Huang, Yi-Hsiang AU - Huang YH AUID- ORCID: 0000-0001-5241-5425 AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Healthcare and Services Center, Taipei Veterans General Hospital, Taipei, Taiwan. AD - Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. FAU - Lee, Fa-Yauh AU - Lee FY AD - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. AD - School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. AD - Therapeutic and Research Center of Liver Cirrhosis and Portal Hypertension, Taipei Veterans General Hospital, Taipei, Taiwan. LA - eng SI - ClinicalTrials.gov/NCT01970748 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20240307 PL - England TA - Gut JT - Gut JID - 2985108R RN - 9Y8NXQ24VQ (Propranolol) SB - IM MH - Humans MH - *Carcinoma, Hepatocellular/complications/surgery MH - *Esophageal and Gastric Varices/complications/surgery MH - Gastrointestinal Hemorrhage/etiology/prevention & control MH - Ligation/adverse effects MH - *Liver Neoplasms/complications/surgery MH - Primary Prevention MH - Propranolol/therapeutic use OTO - NOTNLM OT - HEPATOCELLULAR CARCINOMA OT - OESOPHAGEAL VARICES OT - PORTAL HYPERTENSION COIS- Competing interests: None declared. EDAT- 2023/12/21 00:41 MHDA- 2024/03/11 06:44 CRDT- 2023/12/20 23:56 PHST- 2023/06/04 00:00 [received] PHST- 2023/11/21 00:00 [accepted] PHST- 2024/03/11 06:44 [medline] PHST- 2023/12/21 00:41 [pubmed] PHST- 2023/12/20 23:56 [entrez] AID - gutjnl-2023-330419 [pii] AID - 10.1136/gutjnl-2023-330419 [doi] PST - epublish SO - Gut. 2024 Mar 7;73(4):682-690. doi: 10.1136/gutjnl-2023-330419.