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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02820077
• Other study ID #: NP883/15
• Status: Terminated
• Phase: N/A
• Start date: August 6, 2016
• Est. completion date: August 27, 2020

Study information

• Verified date: August 2020
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: August 27, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Hemorrhage
• Gastrointestinal Neoplasms
• Hemorrhage

Intervention

Device:
• Hemospray (Endoscopic treatment with hemostatic powder)
Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rebleeding		until 30 days after endoscopy
Primary	mortality		until 30 days after endoscopy
Secondary	Successful initial hemostasis		From the moment of the procedure until 24 hours after it
Secondary	Hospital length of stay		from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months