Bleeding at Gastric Cancer Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 32 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 80 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Internal Medicine, | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
within 30 days | No |
| Secondary | 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 | within 2 weeks and 4 weeks | No |
| Secondary | 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. | in 3 days | No |
| Secondary | Rate of additional intervention other than initial endoscopic hemostasis | Definition of Successful hemostasis; controlled bleeding vessel in 5 minute after applying Endo-Clot™ | within 2 weeks to 4 weeks | No |
| Secondary | Mortalities | within 2 weeks to 4 weeks | No |