Current partner codePEPTIDESDE
NCT05331768·Not applicable·INTERVENTIONAL

Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy

Status

Completed

Phase

Not applicable

Enrollment

109

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.

Full detailed description

In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects. Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

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.

Timeline

From registration to results.

  1. First posted

    Apr 18, 2022

  2. Study start

    Jan 1, 2021

  3. Primary completion

    Sep 30, 2021

  4. Study completion

    Sep 30, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Apr 18, 2022

Outcomes

What the study measures.

Primary outcomes

Compare the 24-h group vs 72-h group

Time frame · The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event

Differences between groups at baseline were evaluated with Student's t-test test for continuous variables and proportions were compared using the Chi2 or Fisher test.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * Patients of 18 years and older * Both genders, * Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C) * Acute variceal bleeding were included Exclusion Criteria: * Patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases), * Presence of sepsis, * Multi-organ failure, * The requirement of continuous ionotropic or ventilatory support, * Bleeding disorders, * Hepatocellular carcinoma or other extrahepatic malignanc.

Study locations

1 registered sites.

Mexico. Showing up to 24 locations stored in the fast local snapshot.

Centro Médico Nacional de Occidente

Guadalajara, Jalisco, Mexico

Publications

Results and literature.

PMID 32345507Roesch-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.PMID 33348908Berardo 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.PMID 30697445Boregowda 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.PMID 1421593Bosch 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.PMID 20738780Kalambokis 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.PMID 17185084Kovalak 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.PMID 17879356Garcia-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.PMID 24700393Fortune 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.PMID 18243077Bendtsen 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.PMID 30508958Zhou 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.PMID 11870374Banares 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.PMID 19018483Krag 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.

Primary links

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Related trials

More studies on Terlipressin.

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