Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

April 4, 2016 updated by: Yonsei University

Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer.

Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 19 and less 80 yeas old
  • Gastric cancer was diagnosed with biopsy and/or computed tomography
  • Endoscopic hemostasis is needed upto GI hemorrhage
  • Endoscopic examination is available in 24hours
  • ECOG performance status(PS) <2

Exclusion Criteria:

  • Double primary caner
  • Hypersensitivity of hemostatic power[Endo-Clot(TM)]
  • Variceal bleeding or benign gastric ulcer bleeding
  • Hemodynamically unstable with low systolic BP<90mmHg and/or tachycardia PR>120bpm
  • endoscopic hemostasis within 7 days before screening
  • Contraindication for endoscopic examination
  • Pregnant
  • Breast feeding
  • bleeding tendency with low platelet count <50,000 /mm^3 and/or INR>2
  • Bacterial infection with needs for antibiotics therapy
  • Unavailable to discontinue anti-coagulation agent for 3days
  • Vascular shunt
  • Cardiovascular and/or pulmonary diseases
  • Active hepatitis or severe liver diseases
  • Renal dysfunction
  • Bone marrow dysfunction
  • Neurologic deficit and/or psychotic feature
  • Unavailable informed consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endo-Clot(TM)
Drug: Endo-Clot(TM)
The patients agreed in this study, bleeding control will going to be done with Endo-Clot(TM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate
Time Frame: within 30 days

Proportion of patients who are experience rebleeding events after hemostasis within 30 days expected to be lower than 10 %.

Definition rebleeding events 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.
within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of bleeding control rate
Time Frame: within 2 weeks and 4 weeks
Proportion of patients who are experience successful hemostasis is expected to be higher than 80 %applying Endo-Clot™, Rebleeding rate in 3days, rate of additional intervention other than initial endoscopic hemostasis, Mortalities
within 2 weeks and 4 weeks
Rebleeding rate
Time Frame: in 3 days
Proportion of patients experience rebleeding events after hemostasis within 3 days expected to be lower than 5 %. Definition of Rebleeding rate in 3days 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.
in 3 days
Rate of additional intervention other than initial endoscopic hemostasis
Time Frame: within 2 weeks to 4 weeks
Definition of Successful hemostasis; controlled bleeding vessel in 5 minute after applying Endo-Clot™
within 2 weeks to 4 weeks
Mortalities
Time Frame: within 2 weeks to 4 weeks
within 2 weeks to 4 weeks

Collaborators and Investigators

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

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 27, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share data

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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