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

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ClinicalTrials.gov Identifier: NCT02820077
Recruitment Status : Terminated (Global recall of Hemospray)
First Posted : June 30, 2016
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Hemorrhage Gastrointestinal Neoplasms Device: Hemospray (Endoscopic treatment with hemostatic powder) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
Actual Study Start Date : August 6, 2016
Actual Primary Completion Date : January 24, 2020
Actual Study Completion Date : August 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hemospray
Patients treated with hemostatic powder
Device: Hemospray (Endoscopic treatment with hemostatic powder)
Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

No Intervention: Clinical support
Patients treated with optimal clinical management, as it is been advised by the latest guidelines



Primary Outcome Measures :
  1. rebleeding [ Time Frame: until 30 days after endoscopy ]
  2. mortality [ Time Frame: until 30 days after endoscopy ]

Secondary Outcome Measures :
  1. Successful initial hemostasis [ Time Frame: From the moment of the procedure until 24 hours after it ]
  2. 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 ]


Information from the National Library of Medicine

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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:

  • 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
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Responsible Party: Fauze Maluf Filho, Professor, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02820077    
Other Study ID Numbers: NP883/15
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo:
Endoscopy, Gastrointestinal
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms by Site
Neoplasms
Hemostatics
Coagulants