Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

Upper GI Bleeding Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper GI Bleeding

• NCT number: NCT06167837
• Study type: Interventional
• Source: King Chulalongkorn Memorial Hospital
• Contact: Thanrada Vimonsuntirungsri, MD
• Phone: +66853356240
• Email: aa_choc@docchula.com
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Completion date: June 30, 2025