The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper GI Bleeding

Study Overview
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Brief Summary
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This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.

Official Title
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The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial

Conditions
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Gastro Intestinal Bleeding

Intervention / Treatment
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* Drug: Dextrose 40 % in Water
* Drug: Adrenaline 1 Mg/mL Solution for Injection
* Procedure: argon plasma coagulation
* Procedure: Hemoclip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy Patients consented to study participation Exclusion Criteria: Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip | Drug: Adrenaline 1 Mg/mL Solution for Injection<br>* injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip<br>Procedure: argon plasma coagulation<br>* Thermocoagulation<br>Procedure: Hemoclip<br>* Hemoclip<br>|
| Experimental: Dextrose group<br>Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray | Drug: Dextrose 40 % in Water<br>* injection of adrenaline 1:20.000, followed by dextrose 40% spray<br>Drug: Adrenaline 1 Mg/mL Solution for Injection<br>* injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic success | Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops. | 5 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-bleeding | Number of participants who experience decrease in hemoglobin >1g/dl or need additional hemostatic endoscopy within one week after intervention | 7 days |