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

Primary Purpose

Esophageal Varices

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Octreotide
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    2 Days of octreotide infusion

    5 Days of octreotide infusion

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    December 22, 2021
    Last Updated
    May 17, 2022
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05199038
    Brief Title
    Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study
    Official Title
    Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Varices

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    184 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2 Days of octreotide infusion
    Arm Type
    Experimental
    Arm Title
    5 Days of octreotide infusion
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Octreotide
    Intervention Description
    Octreotide infusion for 2 days in patients with bleeding esophageal varices.
    Primary Outcome Measure Information:
    Title
    Esophageal varices rebleed within 5days after control of initial bleed
    Description
    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
    Time Frame
    with in 5 days after controlof initial bleeding
    Secondary Outcome Measure Information:
    Title
    Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed
    Description
    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
    Time Frame
    5 days - 6 weeks after control of initial bleeding

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Acute esophageal varices bleeding Liver cirrhosis Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mennat -Allah M. El Sawaf, master
    Phone
    00201225548976
    Email
    mennaallah.elsawaf@med.tanta.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29653741
    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. No abstract available. Erratum In: J Hepatol. 2018 Nov;69(5):1207.
    Results Reference
    background
    PubMed Identifier
    28852523
    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.
    Results Reference
    background
    PubMed Identifier
    28533909
    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.
    Results Reference
    background
    PubMed Identifier
    20200386
    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. No abstract available. Erratum In: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text.
    Results Reference
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    PubMed Identifier
    24415445
    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.
    Results Reference
    background
    PubMed Identifier
    22178268
    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.
    Results Reference
    background
    PubMed Identifier
    21484145
    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.
    Results Reference
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    PubMed Identifier
    17879356
    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. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052.
    Results Reference
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    PubMed Identifier
    16904224
    Citation
    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.
    Results Reference
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    Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

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