Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

Last updated: December 11, 2023
Sponsor: King Chulalongkorn Memorial Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Gastric Ulcers

Gastrointestinal Diseases And Disorders

Hemorrhage

Treatment

Metoclopramide Sulfone

Normal Saline 10 mL Injection

Clinical Study ID

NCT06167837
Metoclopramide.UGIB
  • Ages > 18
  • All Genders

Study Summary

This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All adult patients (aged ≥ 18years)
  • Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12hours after onset of bleeding ; Active UGIB was defined as having hematemesis or freshblood by diagnostic gastric lavage at the ER.

Exclusion

Exclusion Criteria:

  • known allergy to metoclopramide
  • prior gastric or duodenal surgery
  • known case of esophageal, gastric or duodenal cancer;
  • advanced HIV infection (defined as WHO criteria13-15: CD4 <200 cell/mm3 or WHOclinical stage 3 or 4)
  • pregnancy
  • gastric lavage was performed with solution > 50 ml.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Metoclopramide Sulfone
Phase: 4
Study Start date:
October 01, 2023
Estimated Completion Date:
June 30, 2025

Study Description

  • This is double-blinded, multicenter RCT including six hospitals in Thailand.

  • The participated endoscopists had work experience for endoscopy more than three years.

  • All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system.

  • The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal.

  • All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation.

  • This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.

Connect with a study center

  • King Chulalongkorn Memorial hospital

    Bangkok, 10330
    Thailand

    Site Not Available

  • King Chulalongkorn memorial hospital

    Bangkok, 10330
    Thailand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.