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

NCT05199038 | Unknown Phase 4

• 1 other identifier: Esophageal Varices Rebleeding
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• Esophageal varices rebleed within 5days after control of initial bleed

  5 days Rebleeding means 1. Recurrence of hematemesis or melena after bleeding control 2. Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100 3. A drop in hemoglobin by more than 20 percentage points from baseline 4. Transfusion of \>2 unites packed red blood cells after endoscopic intervention of variceal bleeding

  with in 5 days after controlof initial bleeding

Secondary Outcomes (1)

• Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed

  5 days - 6 weeks after control of initial bleeding

Study Arms (2)

2 Days of octreotide infusion

EXPERIMENTAL

Drug: Octreotide

5 Days of octreotide infusion

ACTIVE COMPARATOR

Drug: Octreotide

Interventions

Octreotide DRUG

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

2 Days of octreotide infusion; 5 Days of octreotide infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute esophageal varices bleeding
• Liver cirrhosis

You may not qualify if:

• Initial failure to control variceal bleed on endoscopy
• Other causes of GIT bleeding
• Hepatocellular carcinoma
• Portal vein thrombosis
• Renal dialysis and hepatorenal syndrome
• History of myocardial infarction
• Pregnancy or lactation
• Allergy to octreotide

Sponsors & Collaborators

• Tanta University: lead

Related Publications (9)

• 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. No abstract available.

  PMID: 29653741 BACKGROUND

• 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.

  PMID: 28852523 BACKGROUND

• 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.

  PMID: 28533909 BACKGROUND

• 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. No abstract available.

  PMID: 20200386 BACKGROUND

• 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.

  PMID: 24415445 BACKGROUND

• 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.

  PMID: 22178268 BACKGROUND

• 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.

  PMID: 21484145 BACKGROUND

• 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.

  PMID: 17879356 BACKGROUND

• Villanueva C, Piqueras M, Aracil C, Gomez C, Lopez-Balaguer JM, Gonzalez B, Gallego A, Torras X, Soriano G, Sainz S, Benito S, Balanzo 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. doi: 10.1016/j.jhep.2006.05.016. Epub 2006 Jun 28.

  PMID: 16904224 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Mennat -Allah M. El Sawaf, master

CONTACT

00201225548976; mennaallah.elsawaf@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: melsawaf

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 20, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05