Subscribe to RSS
DOI: 10.1055/a-2639-1875
Aggressive versus conservative endotherapy for gastric varices in cirrhosis: a randomized controlled trial
Clinical Trial: Registration number (trial ID): CTRI/2022/02/040188, Trial registry: Clinical Trials Registry India (http://www.ctri.nic.in/Clinicaltrials), Type of Study: Open labelled, Prospective, Randomized, Single-center study
Abstract
Background
Gastric variceal bleeding in cirrhosis remains a challenging clinical problem with variations in management strategies. This randomized controlled trial compared aggressive versus conservative cyanoacrylate therapy for gastric varices in patients with cirrhosis presenting with their first variceal bleed.
Methods
Patients with cirrhosis and large gastric varices (GOV1, GOV2, IGV1) and a first episode of variceal bleeding were randomized to receive aggressive endotherapy (Group A) or conservative endotherapy (Group B). In Group A, all visible gastric varices were obliterated using cyanoacrylate glue; in Group B, only varices with stigmata of recent hemorrhage or high-risk features were treated. The primary outcome was variceal rebleeding at 1 year. Secondary outcomes included all-cause mortality, variceal obliteration time, and adverse events.
Results
145 patients were analyzed (Group A 72; Group B 73). At 1 year, the cumulative incidence of rebleeding was comparable between groups (18.2% vs. 15.0%). All-cause mortality at 1 year was also similar (22.2% vs. 32.9%), with a hazard ratio of 0.63 (95%CI 0.33–1.18; P = 0.15), suggesting a nonsignificant 37% reduction in mortality risk with aggressive endotherapy. Time to obliteration of GOV1 varices was shorter in Group A, with a median (range) of 4 (4–20) vs. 8 (4–116) weeks in Group B. Similarly, the number of endoscopic sessions required for GOV1 obliteration was fewer in Group A (1 [1–4] vs. 2 [1–5] sessions). Adverse event rates were comparable across both groups.
Conclusion
Aggressive endotherapy resulted in rebleeding and mortality rates similar to those of conservative therapy.
Publication History
Received: 20 December 2024
Accepted after revision: 17 June 2025
Accepted Manuscript online:
17 June 2025
Article published online:
19 August 2025
© 2025. Thieme. All rights reserved.
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
-
References
- 1 Sarin SK, Kumar A, Angus PW. et al. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int 2011; 5: 607-624
- 2 Sarin SK, Lahoti D, Saxena SP. et al. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology 1992; 16: 1343-1349
- 3 Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol 1989; 84: 1244-1249
- 4 Wang TJ, Ryou M. Treatment of gastric varices. Curr Hepatol Rep 2024; 23: 287-293
- 5 Hu Y, Zhou M, Liu D. et al. Risk factors for rebleeding after endoscopic injection of cyanoacrylate glue for gastric varices: a systematic review and meta-analysis. Dig Dis Sci 2024; 69: 2890-2903
- 6 de Franchis R, Bosch J, Garcia-Tsao G. et al. Baveno VII Faculty. Baveno VII – renewing consensus in portal hypertension. J Hepatol 2022; 76: 959-974
- 7 Gralnek IM, Camus Duboc M, Garcia-Pagan JC. et al. Endoscopic diagnosis and management of esophagogastric variceal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2022; 54: 1094-1120
- 8 Moher D, Hopewell S, Schulz KF. et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869
- 9 Seewald S, Ang TL, Imazu H. et al. A standardized injection technique and regimen ensures success and safety of N-butyl-2-cyanoacrylate injection for the treatment of gastric fundal varices (with videos). Gastrointest Endosc 2008; 68: 447-454
- 10 Bick BL, Al-Haddad M, Liangpunsakul S. et al. EUS-guided fine needle injection is superior to direct endoscopic injection of 2-octyl cyanoacrylate for the treatment of gastric variceal bleeding. Surg Endosc 2019; 33: 1837-1845
- 11 Lo GH, Lai KH, Cheng JS. et al. A prospective, randomized trial of butyl cyanoacrylate injection versus band ligation in the management of bleeding gastric varices. Hepatology 2001; 33: 1060-1064
- 12 Mishra SR, Chander Sharma B, Kumar A. et al. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut 2010; 59: 729-735
- 13 Mishra SR, Sharma BC, Kumar A. et al. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol 2011; 54: 1161-1167
- 14 Garg M, Gupta T, Goyal S. Cyanoacrylate glue for gastroesophageal varices: a single centre experience from North India. Arq Gastroenterol 2022; 59: 434-438
- 15 Marques P, Maluf-Filho F, Kumar A. et al. Long-term outcomes of acute gastric variceal bleeding in 48 patients following treatment with cyanoacrylate. Dig Dis Sci 2008; 53: 544-550
- 16 Lee YT, Chan FK, Ng EK. et al. EUS-guided injection of cyanoacrylate for bleeding gastric varices. Gastrointest Endosc 2000; 52: 168-174
- 17 D’Imperio N, Piemontese A, Baroncini D. et al. Evaluation of undiluted N-butyl-2-cyanoacrylate in the endoscopic treatment of upper gastrointestinal tract varices. Endoscopy 1996; 28: 239-243
- 18 Kind R, Guglielmi A, Rodella L. et al. Bucrylate treatment of bleeding gastric varices: 12 years’ experience. Endoscopy 2000; 32: 512-519
- 19 Huang YH, Yeh HZ, Chen GH. et al. Endoscopic treatment of bleeding gastric varices by N-butyl-2-cyanoacrylate (Histoacryl) injection: long-term efficacy and safety. Gastrointest Endosc 2000; 52: 160-167
- 20 Kumar A, Singh S, Madan K. et al. Undiluted N-butyl cyanoacrylate is safe and effective for gastric variceal bleeding. Gastrointest Endosc 2010; 72: 721-727
- 21 Hwang SS, Kim HH, Park SH. et al. N-butyl-2-cyanoacrylate pulmonary embolism after endoscopic injection sclerotherapy for gastric variceal bleeding. J Comput Assist Tomogr 2001; 25: 16-22