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TC-325 (HEMOSPRAY™) VS. CURRENT STANDARD OF CARE IN MANAGING MALIGNANT GASTROINTESTINAL BLEEDING: A PILOT STUDY TO INFORM A RANDOMIZED CONTROLLED TRIAL.

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ClinicalTrials.gov Identifier: NCT02135627
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
ASGE
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
Introduction: Gastrointestinal (GI) bleeding arising from malignant tumors is increasingly recognized as a result of oncological advances and improved detection methods, and stems from local vessel damage and tumor invasion with associated derangements in the hemostatic system(1, 2). Although conventional endoscopic hemostasis methods improve outcomes in UGIB due to peptic ulcers and other non-variceal benign bleeding lesions of the upper, and perhaps the lower GI tract, data on their use in hemorrhagic, upper or lower gastrointestinal neoplasms are scarce and associated with varying success in initial hemostasis and high rebleeding rates(3-7). Other recognized single or multimodality treatment approaches include radiation therapy, interventional angiography, and surgery. All exhibit disappointing rebleeding rates, and in the case of emergency surgery, high mortality(4, 8-11). Challenges associated with bleeding tumors include hematological derangements such as thrombocytopenia, disseminated intravascular coagulation, and neutropenia, as well as the endoscopic manipulation of friable, diffusely bleeding surfaces when attempting hemostasis(2, 12, 13). The recent advent of TC-325 (HemosprayTM) to Canada, Europe and Asia - referred henceforth as TC-325 - may provide a highly adapted novel endoscopic hemostatic therapeutic alternative for this refractory clinical entity, with promising uncontrolled observations having just been published by our group(13) and others(14). More robust controlled evaluative data are now needed. We propose to study the use of TC-325 in upper and lower malignant GI bleeding compared to contemporary standard of care, and more specifically seeks funding for a pilot study to inform a subsequent peer-review application for a larger, more definitive randomized clinical trial (RCT).

Condition or disease Intervention/treatment Phase
MALIGNANT GASTROINTESTINAL BLEEDING Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery. Other: Current standard therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control group
Current standard endoscopic therapy such as epinephrine injection, sclerotherapy, mechanical (endoclip). contact electrocautery/thermal, and non-contact electrocalcautery (APC) ± radiation therapy, angioembolization, and/or surgery.
Other: Current standard therapy
Other Names:
  • epinephrine injection,
  • sclerotherapy,
  • mechanical (endoclip).
  • contact electrocautery/thermal
  • non-contact electrocalcautery (APC) ± radiation therapy,
  • angioembolization,
  • surgery

Active Comparator: TC-325
TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.
Drug: TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.



Primary Outcome Measures :
  1. Hemostasis [ Time Frame: 3 minutes after endoscopic therapy ]
    The main outcome will be rate of immediate hemostasis with application of TC-325 or conventional hemostatic therapy. Immediate hemostasis is defined as the absence of bleeding following 3 minutes of observation after endoscopic therapy.


Secondary Outcome Measures :
  1. Rebleeding [ Time Frame: 1, 3, 30, 90 and 180 days following randomization ]
    Rebleeding following randomization

  2. Transfusion [ Time Frame: 30 days after randomization ]
    transfusion requirements

  3. length of ICU admission [ Time Frame: 180 days ]
    need for admission to and length of stay in a monitored care unit

  4. Length of hospitalization [ Time Frame: 180 days ]
    Total length of hospitalization

  5. Complications [ Time Frame: day 1 ]
    Complications associated with endoscopy

  6. Additional treatment modalities [ Time Frame: 30 days ]
    Rates of use of additional treatment modalities to stop persistent bleeding or rebleeding after the index event

  7. Mortality [ Time Frame: 180 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
  • Patients who present with an upper or lower GI bleeding with a known luminal GI malignancy diagnosed within the past two years will be considered for enrolment. Endoscopic confirmation of an active GI bleed arising from a malignant tumor will be required for final inclusion
  • Rebleeding in patients who presented with acute GIB with initial endoscopy suggesting a malignant source based on endoscopic appearance who have not been treated previously with TC-325 will also be included

Exclusion Criteria:

  • Refused by patient
  • Pregnancy
  • Bleeding from non-malignant GI sources such as gastritis/duodenitis, Mallory Weiss syndrome, peptic ulcer disease, varices, vascular malformations, radiation proctitis, polyps, hemorrhoids, and diverticulosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135627


Locations
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Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
ASGE
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02135627    
Other Study ID Numbers: 13-251-BMD
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Epinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents