NCT02820077

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

Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Hemospray (Endoscopic treatment with hemostatic powder)	Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Timeline

• Start date: 2016-08-06
• Primary completion: 2020-01-24
• Completion: 2020-08-27
• First posted: 2016-06-30
• Last updated: 2020-08-31