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

NCT04979273 | Unknown

• 1 other identifier: 20-02-0130
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Intestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Re-bleeding

  7 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Procedure: argon plasma coagulation; Procedure: Hemoclip

Dextrose group

EXPERIMENTAL

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

Drug: Dextrose 40 % in Water; Drug: Adrenaline 1 Mg/mL Solution for Injection

Interventions

Dextrose 40 % in Water DRUG

injection of adrenaline 1:20.000, followed by dextrose 40% spray

Dextrose group

Adrenaline 1 Mg/mL Solution for Injection DRUG

injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip

Control Group; Dextrose group

argon plasma coagulation PROCEDURE

Thermocoagulation

Control Group

Hemoclip PROCEDURE

Hemoclip

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
• Patients consented to study participation

You may not qualify if:

• Patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Glucose; Water; Epinephrine; Solutions; Injections; Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Electrocoagulation; Cautery; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Hasan Maulahela, MD

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Maulahela, MD

CONTACT

+6281283602549; hasanmaulahela@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastrointestinal Endoscopy Center FKUI-RSCM

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

ID (1)