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

Instituto do Cancer do Estado de São Paulo

Status: Terminated

Conditions: Gastrointestinal Hemorrhage; Gastrointestinal Neoplasms

Treatments: Device: Hemospray (Endoscopic treatment with hemostatic powder)

Study type: Interventional

Funder types: Other

Identifiers

NCT02820077

NP883/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Hemospray

Experimental group

Description:

Patients treated with hemostatic powder

Treatment:

Device: Hemospray (Endoscopic treatment with hemostatic powder)

Clinical support

No Intervention group

Description:

Patients treated with optimal clinical management, as it is been advised by the latest guidelines