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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820077

Enrollment

Registered

2016-06-30

Start date

2016-08-06

Completion date

2020-08-27

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage, Gastrointestinal Neoplasms

Keywords

Endoscopy, Gastrointestinal

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.

Interventions

DEVICEHemospray (Endoscopic treatment with hemostatic powder)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
rebleeding	until 30 days after endoscopy
mortality	until 30 days after endoscopy

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026