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

Primary Purpose

Bleeding at Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endo-Clot(TM)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding at Gastric Cancer focused on measuring gastric cancer, bleeding, gastrointestinal hemorrhage

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endo-Clot(TM)

Arm Description

Outcomes

Primary Outcome Measures

Rebleeding rate
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.

Secondary Outcome Measures

Success of bleeding control rate
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
Rebleeding rate
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.
Rate of additional intervention other than initial endoscopic hemostasis
Definition of Successful hemostasis; controlled bleeding vessel in 5 minute after applying Endo-Clot™
Mortalities

Full Information

First Posted
March 27, 2016
Last Updated
April 4, 2016
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02732483
Brief Title
Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding at Gastric Cancer
Keywords
gastric cancer, bleeding, gastrointestinal hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endo-Clot(TM)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Endo-Clot(TM)
Intervention Description
The patients agreed in this study, bleeding control will going to be done with Endo-Clot(TM)
Primary Outcome Measure Information:
Title
Rebleeding rate
Description
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.
Time Frame
within 30 days
Secondary Outcome Measure Information:
Title
Success of bleeding control rate
Description
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
Time Frame
within 2 weeks and 4 weeks
Title
Rebleeding rate
Description
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.
Time Frame
in 3 days
Title
Rate of additional intervention other than initial endoscopic hemostasis
Description
Definition of Successful hemostasis; controlled bleeding vessel in 5 minute after applying Endo-Clot™
Time Frame
within 2 weeks to 4 weeks
Title
Mortalities
Time Frame
within 2 weeks to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Chul Park, MD
Phone
+ 82-2-2228-2272
Email
JUNCHUL75@yuhs.ac
Facility Information:
Facility Name
Department of Internal Medicine,
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chul Park, MD
Phone
+ 82-2-2228-2272
Email
JUNCHUL75@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data
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Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

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