Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding

Study Overview
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Brief Summary
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Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial

Detailed Description
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Patients with active, non-variceal, upper gastrointestinal bleeding usually need an urgent endoscopic treatment. The standard therapy by application of an hemoclip and/or injection of an epinephrine solution is not always successful. Bipolar hemostatic forceps is already being used successfully for the treatment of gastrointestinal bleeding in endoscopic submucosal dissection. Its use in primary endoscopic treatment of non-variceal, upper gastrointestinal bleeding has not been shown yet in a randomized prospective study. Patients with active, non-variceal, upper gastrointestinal bleeding (esophagus or stomach or duodenum) of any cause are randomized (1:1) in standard therapy by combination therapy using an hemoclip and/or injection of an epinephrine solution or experimental therapy by application of the bipolar hemostatic forceps. Cross over-treatment should be tried first in case of failed initial treatment. Rescue treatment by other methods such as application of an Over the Scope Clip (OTSC), angiographic embolization or surgery will be allowed next. All patients receive an additional standard therapy by proton pump inhibitors (PPI). Hypothesis: Endoscopic therapy by application of the bipolar hemostatic forceps is superior to standard therapy regarding technical success and rebleeding rate.

Official Title
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Bipolar Hemostatic Forceps Versus Standard Therapy by Hemoclip and or Epinephrin Injection as Initial Endoscopic Treatment in Acute Non-variceal Upper GI Bleeding: a Prospective, Randomized Multicenter Study

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Procedure: Hemostatic therapy
* Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active, nonvariceal, upper gastrointestinal bleeding Exclusion Criteria: Severe coagulopathy unresponsive to blood products transfusions: platelets <20,000; international normalized ratio >3.0; partial thromboplastin time >2 normal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard therapy<br>Endoscopic therapy with hemoclip +/- injection of epinephrine solution | Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution<br>* Endoscopic therapy with hemoclip +/- injection of epinephrine solution<br>|
| Experimental: Bipolar hemostatic forceps<br>Endoscopic therapy with bipolar hemostatic forceps | Procedure: Hemostatic therapy<br>* Bipolar hemostatic forceps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful primary hemostasis | Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy | 15 minutes | 
| Rebleeding | Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinterventions | Number of endoscopic reinterventions for gastrointestinal bleeding | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis, Endoscopic; Randomized Controlled Trial