NCT03066700

Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Death

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-06-01
• Completion: 2017-08-31
• First posted: 2017-02-28
• Last updated: 2019-02-28

Locations

1 site across 1 country: Thailand