Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

Esophageal Varices Clinical Trial

Official title:

Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05199038
• Other study ID #: Esophageal Varices Rebleeding
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2022
• Est. completion date: November 2023

Study information

• Verified date: May 2022
• Source: Tanta University
• Contact: Mennat -Allah M. El Sawaf, master
• Phone: 00201225548976
• Email: mennaallah.elsawaf[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of 2-days versus 5-days octreotide infusion after endoscopic therapy in preventing early esophageal varices rebleed in patients with cirrhosis.

Description:

Variceal hemorrhage, causative of 70% of all upper gastrointestinal (GIT) bleeding events in patients with portal hypertension, remains one of the most severe and immediate life-threatening complications in patients with cirrhosis and constitutes the second most frequent decompensating event after ascites .

Gastro-esophageal varices are identified in about 30% of patients with compensated cirrhosis and 60% of patients with de-compensated cirrhosis . Esophageal variceal bleeding (EVB) occurs in 10-20% of cirrhotic patients per year and each bleeding episode can be associated with in-hospital mortality .

Mortality during the first episode is estimated to 15-20% but is higher in severe patients (Child Pugh C), at around 30%, whereas it is very low in patients with compensated cirrhosis (Child Pugh A) .The main predictors of bleeding in clinical practice are: large versus small varices, red wale marks, Child Pugh C versus Child Pugh A-B .

Treatment of variceal bleeding should be started as soon as bleeding is clinically confirmed, regardless the lack of confirmation by upper endoscopy . Initial therapy should be directed at restoring blood volume. Vasoactive drug therapy and antibiotic prophylaxis should be initiated as soon as AVB is suspected. Goals of therapy in AVB include the control of bleeding, as well as the prevention of early recurrence and the prevention of six-week mortality .

Starting vasoactive drugs before endoscopy decreases the incidence of active bleeding during endoscopy and facilitates endoscopic therapy, improving the control of bleeding, and potentially survival. Terlipressin, somatostatin or octreotide are accepted drugs with proven efficacy .

Once AVB is confirmed, vasoactive drug therapy should be administered for five days to avoid early rebleeding. Shorter administration of vasoactive drugs (48-72 h) can be considered in less severe episodes although more data are required .The optimal duration of pharmacological therapy has not been well established. In randomized-controlled trials, the duration of vasoactive drugs has varied between 8 h and 6 days .

There was a major agreement that an appropriate length of therapy would be anywhere between 2 and 5 days depending on control of hemorrhage and the presence or absence of predictors of rebleeding .

The combination of endoscopic therapy and vasoactive drugs is more effective than the isolated use of either of these options alone, because it combines the local haemostatic effect on the varices induced by endoscopic treatment and the portal hypotensive effect achieved with drugs. This combination is currently considered the standard of care in AVB .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: November 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute esophageal varices bleeding

2. Liver cirrhosis

Exclusion Criteria:

1. Initial failure to control variceal bleed on endoscopy

2. Other causes of GIT bleeding

3. Hepatocellular carcinoma

4. Portal vein thrombosis

5. Renal dialysis and hepatorenal syndrome

6. History of myocardial infarction

7. Pregnancy or lactation

8. Allergy to octreotide

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Varicose Veins

Intervention

Drug:
• Octreotide
Octreotide infusion for 2 days in patients with bleeding esophageal varices.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

References & Publications (9)

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

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. Erratum in: J Hepatol. 2018 Nov;69(5):1207. — View Citation

Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. Review. Erratum in: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text. — View Citation

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. Erratum in: Hepatology. 2007 Dec;46(6):2052. — View Citation

Haq I, Tripathi D. Recent advances in the management of variceal bleeding. Gastroenterol Rep (Oxf). 2017 May;5(2):113-126. doi: 10.1093/gastro/gox007. Epub 2017 Apr 7. — View Citation

Mallet M, Rudler M, Thabut D. Variceal bleeding in cirrhotic patients. Gastroenterol Rep (Oxf). 2017 Aug;5(3):185-192. doi: 10.1093/gastro/gox024. Epub 2017 Jul 21. Review. — View Citation

Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19. — View Citation

Seo YS, Park SY, Kim MY, Kim JH, Park JY, Yim HJ, Jang BK, Kim HS, Hahn T, Kim BI, Heo J, An H, Tak WY, Baik SK, Han KH, Hwang JS, Park SH, Cho M, Um SH. Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage. Hepatology. 2014 Sep;60(3):954-63. doi: 10.1002/hep.27006. Epub 2014 Jul 25. — View Citation

Villanueva C, Piqueras M, Aracil C, Gómez C, López-Balaguer JM, Gonzalez B, Gallego A, Torras X, Soriano G, Sáinz S, Benito S, Balanzó J. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006 Oct;45(4):560-7. Epub 2006 Jun 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal varices rebleed within 5days after control of initial bleed	5 days Rebleeding means; Recurrence of hematemesis or melena after bleeding control; Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100; A drop in hemoglobin by more than 20 percentage points from baseline; Transfusion of >2 unites packed red blood cells after endoscopic intervention of variceal bleeding	with in 5 days after controlof initial bleeding
Secondary	Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed	5days-6weeks rebleed means; Any new episode of hematemesis, melena, or hematochezia (with sustained tachycardia more than 100 beat/min and drop of systolic blood pressure less than 100); Drop in hemoglobin by more than 20 percentage points OR the need for >2 units packed red blood cells	5 days - 6 weeks after control of initial bleeding