Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy
NCT ID: NCT05331768
Last Updated: 2022-04-18
Study Results
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Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2021-01-01
2021-09-30
Brief Summary
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Detailed Description
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Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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24-h group
The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
banding ligation plus terlipressin infusion
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
72-h group
The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe
banding ligation plus terlipressin infusion
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
Interventions
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banding ligation plus terlipressin infusion
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
Eligibility Criteria
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Inclusion Criteria
* Both genders,
* Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C)
* Acute variceal bleeding were included
Exclusion Criteria
* Presence of sepsis,
* Multi-organ failure,
* The requirement of continuous ionotropic or ventilatory support,
* Bleeding disorders,
* Hepatocellular carcinoma or other extrahepatic malignanc.
18 Years
ALL
Yes
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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GONZALEZ-OJEDA ALEJANDRO
Clinical Professor
Principal Investigators
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Alejandro González-Ojeda
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Centro Médico Nacional de Occidente
Guadalajara, Jalisco, Mexico
Countries
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References
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Roesch-Dietlen F, Gonzalez-Santes M, Sanchez-Maza YJ, Diaz-Roesch F, Cano-Contreras AD, Amieva-Balmori M, Garcia-Zermeno KR, Salgado-Vergara L, Remes-Troche JM, Ortigoza-Gutierrez S. Influence of socioeconomic and cultural factors in the etiology of cirrhosis of the liver. Rev Gastroenterol Mex (Engl Ed). 2021 Jan-Mar;86(1):28-35. doi: 10.1016/j.rgmx.2020.01.002. Epub 2020 Apr 25. English, Spanish.
Berardo C, Di Pasqua LG, Cagna M, Richelmi P, Vairetti M, Ferrigno A. Nonalcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis: Current Issues and Future Perspectives in Preclinical and Clinical Research. Int J Mol Sci. 2020 Dec 17;21(24):9646. doi: 10.3390/ijms21249646.
Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1.
Bosch J, Pizcueta MP, Fernandez M, Feu F, Cirera I, Luca A, Garcia-Pagan JC. Hepatic, splanchnic and systemic haemodynamic abnormalities in portal hypertension. Baillieres Clin Gastroenterol. 1992 Sep;6(3):425-36. doi: 10.1016/0950-3528(92)90030-i.
Kalambokis G, Tsiouris S, Tsianos EV, Baltayiannis G, Pakou B, Fotopoulos A. Effects of terlipressin and somatostatin on liver and thorax blood volumes in patients with cirrhosis. Liver Int. 2010 Oct;30(9):1371-8. doi: 10.1111/j.1478-3231.2010.02322.x.
Kovalak M, Lake J, Mattek N, Eisen G, Lieberman D, Zaman A. Endoscopic screening for varices in cirrhotic patients: data from a national endoscopic database. Gastrointest Endosc. 2007 Jan;65(1):82-8. doi: 10.1016/j.gie.2006.08.023.
Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.
Fortune BE, Groszmann RJ. Combination of splanchnic vasoconstrictors and endoscopic band ligation is an effective treatment strategy for acute variceal hemorrhage; but how do we get those drugs approved by the FDA? Hepatology. 2014 Sep;60(3):789-91. doi: 10.1002/hep.27080. Epub 2014 Jul 28. No abstract available.
Bendtsen F, Krag A, Moller S. Treatment of acute variceal bleeding. Dig Liver Dis. 2008 May;40(5):328-36. doi: 10.1016/j.dld.2007.12.005. Epub 2008 Feb 1.
Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.
Banares R, Albillos A, Rincon D, Alonso S, Gonzalez M, Ruiz-del-Arbol L, Salcedo M, Molinero LM. Endoscopic treatment versus endoscopic plus pharmacologic treatment for acute variceal bleeding: a meta-analysis. Hepatology. 2002 Mar;35(3):609-15. doi: 10.1053/jhep.2002.31354.
Krag A, Borup T, Moller S, Bendtsen F. Efficacy and safety of terlipressin in cirrhotic patients with variceal bleeding or hepatorenal syndrome. Adv Ther. 2008 Nov;25(11):1105-40. doi: 10.1007/s12325-008-0118-7.
Dohler KD, Walker S, Mentz P, Forssmann K, Staritz M. [Vasoconstrictive Therapies for Bleeding Esophageal Varices and their Mechanisms of Action]. Z Gastroenterol. 2003 Oct;41(10):1001-16. doi: 10.1055/s-2003-42931. German.
Salim A, Malik K, Haq IU, Butt AK, Alam A. Comparison of 12-Hour with 72-Hour Terlipressin Therapy for Bleeding Esophageal Varices. J Coll Physicians Surg Pak. 2017 Jun;27(6):334-337.
Moller S, Hansen EF, Becker U, Brinch K, Henriksen JH, Bendtsen F. Central and systemic haemodynamic effects of terlipressin in portal hypertensive patients. Liver. 2000 Feb;20(1):51-9. doi: 10.1034/j.1600-0676.2000.020001051.x.
Yao Q, Chen W, Yan C, Yu J, Jiang T, Cao H. Efficacy and Safety of Treatments for Patients With Portal Hypertension and Cirrhosis: A Systematic Review and Bayesian Network Meta-Analysis. Front Med (Lausanne). 2021 Sep 3;8:712918. doi: 10.3389/fmed.2021.712918. eCollection 2021.
Abid S, Jafri W, Hamid S, Salih M, Azam Z, Mumtaz K, Shah HA, Abbas Z. Terlipressin vs. octreotide in bleeding esophageal varices as an adjuvant therapy with endoscopic band ligation: a randomized double-blind placebo-controlled trial. Am J Gastroenterol. 2009 Mar;104(3):617-23. doi: 10.1038/ajg.2008.147. Epub 2009 Feb 17.
Ioannou G, Doust J, Rockey DC. Terlipressin for acute esophageal variceal hemorrhage. Cochrane Database Syst Rev. 2003;(1):CD002147. doi: 10.1002/14651858.CD002147.
Yeh JH, Lo GH, Huang RY, Lin CW, Wang WL, Perng DS. Short-course vasoconstrictors are adequate for esophageal variceal bleeding after endoscopic variceal ligation: A systematic review and meta-analysis. Sci Prog. 2021 Jul-Sep;104(3):368504211031711. doi: 10.1177/00368504211031711.
Azam Z, Hamid S, Jafri W, Salih M, Abbas Z, Abid S, Shah H. Short course adjuvant terlipressin in acute variceal bleeding: a randomized double blind dummy controlled trial. J Hepatol. 2012 Apr;56(4):819-24. doi: 10.1016/j.jhep.2011.11.019. Epub 2011 Dec 16.
Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.
Other Identifiers
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Terlipressin proyect
Identifier Type: -
Identifier Source: org_study_id
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