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

Dr Cipto Mangunkusumo General Hospital

Status: Unknown

Conditions: Gastro Intestinal Bleeding

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04979273

20-02-0130

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip

Treatment:

Procedure: argon plasma coagulation

Procedure: Hemoclip

Drug: Adrenaline 1 Mg/mL Solution for Injection

Dextrose group

Experimental group

Description:

Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray

Treatment:

Drug: Adrenaline 1 Mg/mL Solution for Injection

Drug: Dextrose 40 % in Water