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EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding (EVL)

Primary Purpose

Esophageal Varices, Bleeding

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pantoloc 40 mg
somatostatin or terlipressin
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Varices focused on measuring control of bleed

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The etiology of portal hypertension is cirrhosis.
  • Age ranges between 18-80 y/o.
  • Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: (1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or (2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
  • EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.

Exclusion Criteria:

  • Association with severe systemic illness, such as sepsis, COPD, uremia
  • Association with gastric variceal bleeding
  • Failure in the control of bleeding by emergency EVL
  • Moribund patients, died within 12 hours of enrollment
  • Uncooperative
  • Ever received EIS, EVL within one month prior to index bleeding
  • Child-Pugh's scores > 13

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    EVL + vasoconstrictor

    EVL + PPI

    Arm Description

    Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.

    Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5

    Outcomes

    Primary Outcome Measures

    Success rate of initial hemostasis
    Definition of initial hemostasis Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria. Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.
    very early rebleeding
    Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.

    Secondary Outcome Measures

    The amount of blood transfusion within 42 days
    The amount of blood transfusion during admission was recorded.
    Mortality
    Mortality within 42 days was recorded and compared.
    The size and number of ulcers on varices
    If p't agrees, a second look endoscopy is performed to detect ulcers.

    Full Information

    First Posted
    April 23, 2010
    Last Updated
    April 27, 2010
    Sponsor
    National Science Council, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01112852
    Brief Title
    EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding
    Acronym
    EVL
    Official Title
    A Randomized, Controlled Trial of Ligation Plus Vasoconstrictor vs.Ligation Plus Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Science Council, Taiwan

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
    Detailed Description
    Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL. Thus, we designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus somatostatin infusion or losec infusion for 5 days. AIMS: To investigate whether the combination of EVL and somatostatin is superior to the combination of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding and very early rebleeding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Varices, Bleeding
    Keywords
    control of bleed

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EVL + vasoconstrictor
    Arm Type
    Active Comparator
    Arm Description
    Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
    Arm Title
    EVL + PPI
    Arm Type
    Experimental
    Arm Description
    Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5
    Intervention Type
    Drug
    Intervention Name(s)
    pantoloc 40 mg
    Other Intervention Name(s)
    pantoloc, a proton pump inhibitor
    Intervention Description
    pantoloc iv. infusion per day
    Intervention Type
    Drug
    Intervention Name(s)
    somatostatin or terlipressin
    Other Intervention Name(s)
    somatostatin and terlipressin are vasoconstrictors.
    Intervention Description
    Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
    Primary Outcome Measure Information:
    Title
    Success rate of initial hemostasis
    Description
    Definition of initial hemostasis Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria. Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.
    Time Frame
    5 days
    Title
    very early rebleeding
    Description
    Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.
    Time Frame
    48-120 hours after treatment
    Secondary Outcome Measure Information:
    Title
    The amount of blood transfusion within 42 days
    Description
    The amount of blood transfusion during admission was recorded.
    Time Frame
    42 days
    Title
    Mortality
    Description
    Mortality within 42 days was recorded and compared.
    Time Frame
    within 42 days
    Title
    The size and number of ulcers on varices
    Description
    If p't agrees, a second look endoscopy is performed to detect ulcers.
    Time Frame
    2 weeks after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The etiology of portal hypertension is cirrhosis. Age ranges between 18-80 y/o. Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: (1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or (2) when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding). EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested. Exclusion Criteria: Association with severe systemic illness, such as sepsis, COPD, uremia Association with gastric variceal bleeding Failure in the control of bleeding by emergency EVL Moribund patients, died within 12 hours of enrollment Uncooperative Ever received EIS, EVL within one month prior to index bleeding Child-Pugh's scores > 13
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gin-Ho Lo
    Organizational Affiliation
    E-DA Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23278466
    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.
    Results Reference
    derived

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    EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding

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