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

Not Applicable

• Conditions: Gastro Intestinal Bleeding
• Interventions: Drug: Dextrose 40 % in Water; Drug: Adrenaline 1 Mg/mL Solution for Injection; Procedure: argon plasma coagulation; Procedure: Hemoclip

• Registration Number: NCT04979273
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-23
• Last Update Submitted: 2021-07-23
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose group	Adrenaline 1 Mg/mL Solution for Injection	Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
Control Group	argon plasma coagulation	Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
Control Group	Adrenaline 1 Mg/mL Solution for Injection	Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
Dextrose group	Dextrose 40 % in Water	Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
Control Group	Hemoclip	Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip

Primary Outcome Measures

Name	Time	Method
Hemostatic success	5 minute	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.

Secondary Outcome Measures

Name	Time	Method
Re-bleeding	7 days	Number of participants who experience decrease in hemoglobin \>1g/dl or need additional hemostatic endoscopy within one week after intervention

Trial Locations

Locations (1)

Dr. Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia