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

NCT ID: NCT02820077

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-06
• Study Completion Date: 2020-08-27

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.

Conditions

Gastrointestinal Hemorrhage; Gastrointestinal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hemospray

Patients treated with hemostatic powder

Group Type: EXPERIMENTAL

Hemospray (Endoscopic treatment with hemostatic powder)

Intervention Type: DEVICE

Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Clinical support

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hemospray (Endoscopic treatment with hemostatic powder)

Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fauze Maluf Filho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NP883/15

Identifier Type: -

Identifier Source: org_study_id