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

Yonsei University

Status and phase: Unknown; Phase 2

Conditions: Bleeding at Gastric Cancer

Treatments: Drug: Endo-Clot(TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02732483

4-2016-0031

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Endo-Clot(TM)

Experimental group

Treatment:

Drug: Endo-Clot(TM)