Efficacy of Hemostatic Powder, Endo-ClotTM in the Endoscopic Treatment of Acute Upper Gastrointestinal Bleeding

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 63
• Participant gender: Both

Summary

Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.

EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a single center, prospective study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Hemostatics
• Last Updated: 2016-03-18

Criteria

Inclusion Criteria:

A. Older than 19 years old B. Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding C. Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding D. Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding

Exclusion Criteria:

A. Patients who had diagnosed esophageal cancer or stomach cancer B. Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma C. coagulation disorder (hemophilia, ITP,,) D. Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..) E. Patients who cannot undergo EGD because of anatomical problem, unconsciousness.

F. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism