Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial

Mohamed A Elsebaey, Mohamed A Tawfik, Sherif Ezzat, Amal Selim, Heba Elashry, Sherief Abd-Elsalam, Mohamed A Elsebaey, Mohamed A Tawfik, Sherif Ezzat, Amal Selim, Heba Elashry, Sherief Abd-Elsalam

Abstract

Background: The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients.

Methods: This prospective study included 113 cirrhotic patients with actively bleeding esophageal varices. They were randomly treated by endoscopic sclerotherapy or cyanoacrylate injection as banding was not suitable for those patients due to profuse bleeding making unclear endoscopic visual field. Primary outcome was incidence of active bleeding control and secondary outcomes were incidence of six weeks rebleeding, complications, and mortality among the studied patients.

Results: Initial bleeding control was significantly higher in cyanoacrylate versus sclerotherapy groups (98.25, 83.93% respectively, P = 0.007). No significant differences between sclerotherapy and cyanoacrylate groups regarding rebleeding (26.79, 19.30% respectively, P = 0.344), complications, hospital stay or mortality rate were observed.

Conclusions: Based on this single-center prospective study, both of these therapies appear to have relatively favorable outcomes, although cyanoacrylate injection may be superior to sclerotherapy for initial control of active bleeding.

Trial registration: [ClinicalTrials.gov Identifier: NCT03388125 ]-Date of registration: January 2, 2018 "Retrospectively registered".

Keywords: Cyanoacrylate injection; Esophageal varices; iInjection sclerotherapy.

Conflict of interest statement

Competing interest

The authors declare that they have no competing interests.

Ethics approval and consent to participate

The study protocol was done in accordance to the ethical guidelines of the 1975 Helsinki Declaration. The study protocol was approved by the Research Ethics Committee of Quality Assurance Unit of Faculty of Medicine, Tanta University with approval code 1734/03/13. A written informed consent was obtained from all included patients in this study. Our study adheres to CONSORT guidelines.

Consent for publication

Not applicable.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The Kaplan-Meier curve of rebleedings

References

    1. Krige JE, Shaw JM, Bornman PC. The evolving role of endoscopic treatment for bleeding esophageal varices. World J Surg. 2005;29:966–973. doi: 10.1007/s00268-005-0138-2.
    1. Jensen DM. Endoscopic screening of varices in cirrhosis: findings, implications and outcomes. J Gastroenterol. 2002;122:1620–1630. doi: 10.1053/gast.2002.33419.
    1. Arafa N, EL Hoseiny M, Rekacewicz C, et al. Changing pattern of hepatitis C virus spread in rural areas of Egypt. J Heaptol. 2005;43:418–424. doi: 10.1016/j.jhep.2005.03.021.
    1. Shalaby SI, Abo-Eldahab M, Abd-Elhafeez H, Awad MA, Medhat Attia M, Gupta N. Clinical and clinico-pathological impacts of upper gastrointestinal bleeding in elderly Egyptian patients. IOSR J Pharm aBiol Sci. 2016;11(6):25–30.
    1. De Franchis R, Bosch J, Burroughs AK, et al. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010;53:762–768. doi: 10.1016/j.jhep.2010.06.004.
    1. Esmat GE, Hamza IM, Abbas BE, Hashem AM, Ghoneim HS. Management of acute esophageal variceal bleeding by endoscopic sclerotherapy in technically difficult endoscopic band ligation cases—a population based cohort study. Open J Gastroenterol. 2013;3:281–287. doi: 10.4236/ojgas.2013.35048.
    1. Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W. Practice guidelines committee of the AASLD, practice parameters committee of the ACG. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007;46(3):922–938. doi: 10.1002/hep.21907.
    1. Bendtsen F, Krag A, Møller S. Treatment of acute variceal bleeding. Dig Liver Dis. 2008;40:328–336. doi: 10.1016/j.dld.2007.12.005.
    1. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60:646–649. doi: 10.1002/bjs.1800600817.
    1. National institute for Health and Care Excellence. Acute upper gastrointestinal bleeding: management. NICE 2012; Guideline No. CG141.
    1. Chavez-Tapia NC, Barrientos-Gutierrez T, Tellez-Avila FI, Soares-Weiser K, Uribe M. Antibiotic prophylaxis for cirrhotic patients with upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2010;9:CD002907.
    1. Augustin S, González A, Genescà J. Acute esophageal variceal bleeding: current strategies and new perspectives. World J Hepatol. 2010;2(7):261–274. doi: 10.4254/wjh.v2.i7.261.
    1. Cipolletta L, Zambelli A, Bianco MA, et al. Acrylate glue injection for acutely bleeding oesophageal varices: a prospective cohort study. Dig Liver Dis. 2009;41:729–734. doi: 10.1016/j.dld.2009.02.006.
    1. Japanese Research Society for Portal Hypertension The general rules for recording endoscopic findings on esophageal varices. Japanese J Surg. 1980;10:84–87. doi: 10.1007/BF02468653.
    1. De Franchis R. Evolving consensus in portal hypertension. Report of the Baveno IV consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2005;43:167–176. doi: 10.1016/j.jhep.2005.05.009.
    1. Thongbai T, Thanapirom K, Ridtitid W, Rerknimitr R, Thungsuk R, Noophun P, et al. Factors predicting mortality of elderly patients with acute upper gastrointestinal bleeding. Asian Biomedicine. 2016;10(2):115–122. doi: 10.5372/1905-7415.1002.471.
    1. Maluf-Filho F, Sakai P, Ishioka S, Matuguma SE. Endoscopic sclerosis versus cyanoacrylate endoscopic injection for the first episode of variceal bleeding: a prospective, controlled, and randomized study in child-Pugh class C patients. Endoscopy. 2001;33(5):421–427. doi: 10.1055/s-2001-14257.
    1. Tan PC, Hou MC, Lin HC, et al. A randomized trial of endoscopic treatment of acute gastric variceal haemorrhage: N butyl-2-cyanoacrylate injection versus band ligation. Hepatology. 2006;43:690–697. doi: 10.1002/hep.21145.
    1. LJubičić N, Bišćanin A, Nikolić M, et al. Randomized-controlled trial of endoscopic treatment of acute esophageal variceal hemorrhage: N-Butyl-2-cyanoacrylate injection vs. Variceal Ligation Hepato-Gastroenterology. 2011;58:1–6.
    1. Sauerbruch T, Weinzierl M, Kopcke W, Paumgartner G. Long-term sclerotherapy of bleeding esophageal varices in patients with liver cirrhosis. An evaluation of mortality and rebleeding risk factors. Scand J Gastroenterol. 1985;20:51–58. doi: 10.3109/00365528509089632.
    1. Amer K, Jouda A, Abdel Monem SM. Different factors correlated to early Rebleeding in cirrhotic patients treated by variceal band ligation versus endoscopic sclerotherapy. Afro-Egypt J Infect Endem Dis. 2016;6(1):48–58. doi: 10.21608/aeji.2016.9629.
    1. Park WG, Yeh RW, Triadafilopoulos G. Injection therapies for variceal bleeding disorders of the GI tract. GastrointestEndosc. 2008;67:313–323.

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