Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

Liver Cirrhosis Clinical Trial

— CER:T  

Official title:

Comparative Effectiveness Research: Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails to Treat the Patients With Acute Variceal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02311608
• Other study ID #: CSY-LB2-2014
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2014
• Last updated: December 5, 2014
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2014
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13701761310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

To observe and access the Effects and safety of terlipressin or high dose somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in patients with acute variceal bleeding.

Description:

The prognosis information of the patients with acute variceal bleeding will be collected, including hemostasis rate, early rebleeding rate, mortality, complications, severity adverse events, economic burdens and quality of life, when terlipressin or high dose somatostatin/octreotide is used as salvation to patients fail to achieve initial hemostasis.The results may help gastroenterologists to make decisions when administering vasoactive medicines to those suffered from acute variceal bleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1320
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding

Exclusion Criteria:

• No signs of variceal bleeding are found by endoscopy or portal hypertensive gastropathy is responsible for the bleeding

• Patients undergo endoscopy after 72h from the beginning of acute variceal bleeding

• Patients with hepatorenal syndrome

• Patients with ischemia organic cardiopathy (including myocardial infarction or unstable angina pectoris) or myocardial ischemia indicated by ECG in the past 6 months

• Patients allergic to/with contraindications of vasoactive drugs

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Hemorrhage
• Liver Cirrhosis

Intervention

Drug:
• Terlipressin
administered as a first-line medicine or as salvage
• Usual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
• High Dose Somatostatin/Octreotide
administered as salvage

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View Citation

Baik SK, Jeong PH, Ji SW, Yoo BS, Kim HS, Lee DK, Kwon SO, Kim YJ, Park JW, Chang SJ, Lee SS. Acute hemodynamic effects of octreotide and terlipressin in patients with cirrhosis: a randomized comparison. Am J Gastroenterol. 2005 Mar;100(3):631-5. — View Citation

D'Amico G, Pietrosi G, Tarantino I, Pagliaro L. Emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis: a Cochrane meta-analysis. Gastroenterology. 2003 May;124(5):1277-91. — View Citation

Escorsell A, Ruiz del Arbol L, Planas R, Albillos A, Bañares R, Calès P, Pateron D, Bernard B, Vinel JP, Bosch J. Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: the TEST study. Hepatology. 2000 Sep;32(3):471-6. — View Citation

Fabrizi F, Dixit V, Martin P. Meta-analysis: terlipressin therapy for the hepatorenal syndrome. Aliment Pharmacol Ther. 2006 Sep 15;24(6):935-44. Review. — View Citation

Kalambokis G, Economou M, Paraskevi K, Konstantinos P, Pappas C, Katsaraki A, Tsianos EV. Effects of somatostatin, terlipressin and somatostatin plus terlipressin on portal and systemic hemodynamics and renal sodium excretion in patients with cirrhosis. J Gastroenterol Hepatol. 2005 Jul;20(7):1075-81. — View Citation

Lo GH, Chen WC, Wang HM, Lin CK, Chan HH, Tsai WL, Cheng LC, Yu HC, Tsay FW. Low-dose terlipressin plus banding ligation versus low-dose terlipressin alone in the prevention of very early rebleeding of oesophageal varices. Gut. 2009 Sep;58(9):1275-80. doi: 10.1136/gut.2008.165910. Epub 2009 Apr 21. — View Citation

Lo GH, Perng DS, Chang CY, Tai CM, Wang HM, Lin HC. Controlled trial of ligation plus vasoconstrictor versus proton pump inhibitor in the control of acute esophageal variceal bleeding. J Gastroenterol Hepatol. 2013 Apr;28(4):684-9. doi: 10.1111/jgh.12107. — View Citation

Romero G, Kravetz D, Argonz J, Bildozola M, Suarez A, Terg R. Terlipressin is more effective in decreasing variceal pressure than portal pressure in cirrhotic patients. J Hepatol. 2000 Mar;32(3):419-25. — View Citation

Solà E, Lens S, Guevara M, Martín-Llahí M, Fagundes C, Pereira G, Pavesi M, Fernández J, González-Abraldes J, Escorsell A, Mas A, Bosch J, Arroyo V, Ginès P. Hyponatremia in patients treated with terlipressin for severe gastrointestinal bleeding due to portal hypertension. Hepatology. 2010 Nov;52(5):1783-90. doi: 10.1002/hep.23893. — View Citation

Villanueva C, Planella M, Aracil C, López-Balaguer JM, González B, Miñana J, Balanzó J. Hemodynamic effects of terlipressin and high somatostatin dose during acute variceal bleeding in nonresponders to the usual somatostatin dose. Am J Gastroenterol. 2005 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change of Rebleeding Rate		1month, 3months, 6 months, 12 months	No
Secondary	Economic Cost		up to 12 months	No
Secondary	The Change of Quality of Life		1month, 3months, 6 months, 12 months	No
Secondary	The Change of Survival Rate		1month, 3months, 6 months, 12 months	No
Secondary	The Change of Complication Rate		1month, 3months, 6 months, 12 months	Yes
Secondary	The Change of Drug Adverse Reaction Rate		1month, 3months, 6 months, 12 months	Yes