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

August 27, 2020 updated by: Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemospray
Patients treated with hemostatic powder
Device: Hemospray (Endoscopic treatment with hemostatic powder)
Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards
No Intervention: Clinical support
Patients treated with optimal clinical management, as it is been advised by the latest guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rebleeding
Time Frame: until 30 days after endoscopy
until 30 days after endoscopy
mortality
Time Frame: until 30 days after endoscopy
until 30 days after endoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful initial hemostasis
Time Frame: From the moment of the procedure until 24 hours after it
From the moment of the procedure until 24 hours after it
Hospital length of stay
Time Frame: from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months
from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2016

Primary Completion (Actual)

January 24, 2020

Study Completion (Actual)

August 27, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP883/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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