Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

Death Clinical Trial

Official title:

Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066700
• Other study ID #: RP012
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: February 2019
• Source: King Chulalongkorn Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 31, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Thailand	King chulalongkorn memorial hospita	Bangkok	Pathum Wan

Sponsors (2)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital	McGill University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Death rate after applying HemosprayTM	6 months
Secondary	Rebleeding rate	Bleeding from tumor after applying HemosprayTM	30 days