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Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage

Primary Purpose

Gastric Variceal Bleeding

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cyanoacrylate
Cyanoacrylate
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Variceal Bleeding focused on measuring gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with liver cirrhosis and/or hepatoma
  • Aged 18 to 80, who had endoscopy-proven acute GVB
  • Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
  • Endoscopic signs of active bleeding from the GV
  • Adherent blood clots, white nipple signs, or erosions on the GV
  • The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
  • Who or their legally authorized representatives gave informed consent

Exclusion Criteria:

  • Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
  • Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    A

    B

    Arm Description

    Single dose cyanoacrylate in one shot

    Double doses cyanoacrylate in one shot

    Outcomes

    Primary Outcome Measures

    Rebleeding

    Secondary Outcome Measures

    Survival

    Full Information

    First Posted
    August 12, 2008
    Last Updated
    October 4, 2010
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00735358
    Brief Title
    Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.
    Detailed Description
    Although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as promising because of its high rebleeding rate around 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. Each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. Therefore we designed a randomized trial to test the hypothesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Variceal Bleeding
    Keywords
    gastric variceal bleeding, cyanoacrylate, rebleeding, complication, survival, acute gastric variceal bleeding

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    Single dose cyanoacrylate in one shot
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    Double doses cyanoacrylate in one shot
    Intervention Type
    Procedure
    Intervention Name(s)
    Cyanoacrylate
    Intervention Description
    Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot
    Intervention Type
    Procedure
    Intervention Name(s)
    Cyanoacrylate
    Intervention Description
    Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
    Primary Outcome Measure Information:
    Title
    Rebleeding
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Survival
    Time Frame
    2 year

    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: Patients with liver cirrhosis and/or hepatoma Aged 18 to 80, who had endoscopy-proven acute GVB Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena Endoscopic signs of active bleeding from the GV Adherent blood clots, white nipple signs, or erosions on the GV The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources Who or their legally authorized representatives gave informed consent Exclusion Criteria: Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19559427
    Citation
    Hou MC, Lin HC, Lee HS, Liao WC, Lee FY, Lee SD. A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL. Gastrointest Endosc. 2009 Oct;70(4):668-75. doi: 10.1016/j.gie.2009.02.005. Epub 2009 Jun 25.
    Results Reference
    derived

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    Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage

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