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

Not Applicable

Terminated

• Conditions: Gastrointestinal Hemorrhage; Gastrointestinal Neoplasms
• Interventions: Device: Hemospray (Endoscopic treatment with hemostatic powder)

• Registration Number: NCT02820077
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Study Start: 2016-08-06
• Primary Completion: 2020-01-24
• Status Verified: 2020-08
• Study Completion: 2020-08-27
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemospray	Hemospray (Endoscopic treatment with hemostatic powder)	Patients treated with hemostatic powder

Primary Outcome Measures

Name	Time	Method
mortality	until 30 days after endoscopy
rebleeding	until 30 days after endoscopy

Secondary Outcome Measures

Name	Time	Method
Successful initial hemostasis	From the moment of the procedure until 24 hours after it
Hospital length of stay	from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months