NCT06167837

Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Upper GI Bleeding

Interventions

Type	Name	Description
DRUG	Metoclopramide Sulfone	Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD
DRUG	Normal Saline 10 mL Injection	Normal saline 10 ml IV 30-60 minutes before EGD

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-05-01
• Completion: 2025-06-30
• First posted: 2023-12-13
• Last updated: 2023-12-13

Locations

2 sites across 1 country: Thailand