Variceal Hemorrhage
Conditions
Brief summary
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.
Interventions
Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission. once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed. Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy. Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure. Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care
Sponsors
Study design
Eligibility
Inclusion criteria
: * 18 Years and older * Bleeding Esophageal and / or Gastric varices
Exclusion criteria
* Patient is: \< 18 years of age * Unable to consent * Contraindicated to undergo endoscopy, * Already hospitalized for another illness * Pregnant or lactating * Patients with altered post-surgical anatomy of the stomach * Previously placed intrahepatic portosystemic shunt * Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 24 hours | Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 24 hours | Information on efficacy will be obtained by measurements the proportion of patients with acute (procedural) hemostasis, and the rate of recurrent bleeding within 72 hours of treatment. |
Countries
Belgium, Egypt