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Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

Primary Purpose

Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hemospray (Endoscopic treatment with hemostatic powder)
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Hemorrhage focused on measuring Endoscopy, Gastrointestinal

Eligibility Criteria

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

Inclusion Criteria:

  • Any kind of malignancy
  • Gastrointestinal bleeding in the last 48 hours
  • Referred to emergency endoscopy

Exclusion Criteria:

  • under 18 years old
  • bleeding from non malignant lesions
  • previous endoscopic treatment with another method done in the last 48h

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hemospray

    Clinical support

    Arm Description

    Patients treated with hemostatic powder

    Patients treated with optimal clinical management, as it is been advised by the latest guidelines

    Outcomes

    Primary Outcome Measures

    rebleeding
    mortality

    Secondary Outcome Measures

    Successful initial hemostasis
    Hospital length of stay

    Full Information

    First Posted
    June 7, 2016
    Last Updated
    August 27, 2020
    Sponsor
    Instituto do Cancer do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02820077
    Brief Title
    Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
    Official Title
    Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Global recall of Hemospray
    Study Start Date
    August 6, 2016 (Actual)
    Primary Completion Date
    January 24, 2020 (Actual)
    Study Completion Date
    August 27, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Instituto do Cancer do Estado de São Paulo

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.
    Detailed Description
    Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high. Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms
    Keywords
    Endoscopy, Gastrointestinal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hemospray
    Arm Type
    Experimental
    Arm Description
    Patients treated with hemostatic powder
    Arm Title
    Clinical support
    Arm Type
    No Intervention
    Arm Description
    Patients treated with optimal clinical management, as it is been advised by the latest guidelines
    Intervention Type
    Device
    Intervention Name(s)
    Hemospray (Endoscopic treatment with hemostatic powder)
    Intervention Description
    Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards
    Primary Outcome Measure Information:
    Title
    rebleeding
    Time Frame
    until 30 days after endoscopy
    Title
    mortality
    Time Frame
    until 30 days after endoscopy
    Secondary Outcome Measure Information:
    Title
    Successful initial hemostasis
    Time Frame
    From the moment of the procedure until 24 hours after it
    Title
    Hospital length of stay
    Time Frame
    from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any kind of malignancy Gastrointestinal bleeding in the last 48 hours Referred to emergency endoscopy Exclusion Criteria: under 18 years old bleeding from non malignant lesions previous endoscopic treatment with another method done in the last 48h

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

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