Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

Completed

• Conditions: Death
• Interventions: Device: Hemostatic powder

• Registration Number: NCT03066700
• Lead Sponsor: King Chulalongkorn Memorial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-28
• Study Start: 2017-03-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-08-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemospray application	Hemostatic powder	The patients with GI bleeding from tumor and received Hemospray as a hemostasis method.

Primary Outcome Measures

Name	Time	Method
Mortality rate	6 months	Death rate after applying HemosprayTM

Secondary Outcome Measures

Name	Time	Method
Rebleeding rate	30 days	Bleeding from tumor after applying HemosprayTM

Trial Locations

Locations (1)

King chulalongkorn memorial hospita; 🇹🇭 Bangkok, Pathum Wan, Thailand