Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

NCT ID: NCT03066700

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-08-31

Brief Summary

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This is a retrospective study to identify the prognostic factors of the good outcomes in patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode and also 6-month survival rate.

Detailed Description

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Tumor-related gastrointestinal (GI) bleeding is increasing due to the advancement of treatment in oncology. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. Surgery, embolization, and radiotherapy can served as the salvage hemostasis; though, a bridging endoscopic therapy is required during resuscitation and stabilization of the patients. Hemospray is a recent novel endoscopic hemostatis powder which has a trend to be an effective instrument for controlling the active upper GI tumor bleeding from a match-pair, case-control study by the author's recent publication. Consequently, the authors hypothesized that there are some prognostic factors related to the outcome of Hemospray treatment in tumor bleeding.

Conditions

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Death

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hemospray application

The patients with GI bleeding from tumor and received Hemospray as a hemostasis method.

Hemostatic powder

Intervention Type DEVICE

HemosprayTM (Tc-325) is an endoscopic hemostatis powder that came onto market recently. It is made of an inorganic, non-absorbable powder which acts locally at the mucosa. When spraying the powder on to the bleeding site, it creates an adherent stable barrier sheath that allows for at least temporary hemostasis. Neither luminal nor systemic side effects have been reported to date.

Interventions

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Hemostatic powder

HemosprayTM (Tc-325) is an endoscopic hemostatis powder that came onto market recently. It is made of an inorganic, non-absorbable powder which acts locally at the mucosa. When spraying the powder on to the bleeding site, it creates an adherent stable barrier sheath that allows for at least temporary hemostasis. Neither luminal nor systemic side effects have been reported to date.

Intervention Type DEVICE

Other Intervention Names

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HemosprayTM

Eligibility Criteria

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Inclusion Criteria

* All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role collaborator

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rapat Pittayanon, MD

Principle investigator, Gastrointestinal Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King chulalongkorn memorial hospita

Bangkok, Pathum Wan, Thailand

Site Status

Countries

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Thailand

References

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Pittayanon R, Rerknimitr R, Barkun A. Prognostic factors affecting outcomes in patients with malignant GI bleeding treated with a novel endoscopically delivered hemostatic powder. Gastrointest Endosc. 2018 Apr;87(4):994-1002. doi: 10.1016/j.gie.2017.11.013. Epub 2017 Nov 20.

Reference Type DERIVED
PMID: 29158179 (View on PubMed)

Other Identifiers

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RP012

Identifier Type: -

Identifier Source: org_study_id

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