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

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.

Study Overview

• Status: Recruiting
• Conditions: Upper GI Bleeding
• Intervention / Treatment: Drug: Metoclopramide Sulfone; Drug: Normal Saline 10 mL Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thanrada Vimonsuntirungsri, MD; Phone Number: +66853356240; Email: aa_choc@docchula.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • King Chulalongkorn Memorial Hospital
    • Contact: Thanrada Vimonsuntirungsri, MD; Phone Number: +66853356240; Email: aa_choc@docchula.com
  • Bangkok, Thailand, 10330
    • Not yet recruiting
    • King Chulalongkorn Memorial Hospital
    • Sub-Investigator: Thanrada Vimonsuntirungsri, MD
    • Contact: Thanrada Vimonsuntirungsri; Phone Number: 66853356240; Email: aa_choc@docchula.com
    • Principal Investigator: Rapat Pittayanon, MD, MSc
    • Sub-Investigator: Natee Faknak, MD
    • Sub-Investigator: Nutbordee Nalinthassanai, MD
    • Sub-Investigator: Thaninee Prasoppokakorn, MD
    • Sub-Investigator: Nicha Teeratorn, MD
    • Sub-Investigator: Yingluk Sritunyarat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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 WHO clinical stage 3 or 4)
• pregnancy
• gastric lavage was performed with solution > 50 ml.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metoclopramide group; Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD	Drug: Metoclopramide Sulfone; Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD
Placebo Comparator: Placebo group; NSS 10 ml IV 30-60 min before EGD	Drug: Normal Saline 10 mL Injection; Normal saline 10 ml IV 30-60 minutes before EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with 'adequate visualization'	'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score >=6 considered as adequate visualization	Through study completion, estimate 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean difference in EVS	total of four locations and at each location including fundus, corpus, antrum and duodenal bulb	Through study completion, estimate 2 years
Duration of esophagogastroduodenoscopy		10minutes to 2 hours
Immediate hemostasis	Rate of succession of hemostasis (bleeding stop) at first EGD	Through study completion, estimate 2 years
The need for a second look EGD within 72 hours after initial endoscopy	Rate of need for a second look EGD within 72 hours after initial endoscopy The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met: I) hematemesis or bloody nasogastric tube (NG) > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR ≥ 110 bpm) or hypotension(SBP ≤ 90 mmHg) after ≥ 1 hour of vital sign stability without other cause; V) hemoglobin drop of ≥ 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) ≥ 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia.	Up to 72 hours
Number of unit of red blood cell transfusion during first 24 hours	Number of of unit of red blood cell transfusions during first 24 hours	Up to 24 hours
Length of hospital stays	Length of hospital stays of participants	1day - 30days
30-day rebleeding rate	rate of 30-day rebleeding of upper GI tract	Up to 30 days

Collaborators and Investigators

• Sponsor: King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Estimated): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: EGD; Metoclopramide; Gastric visualization; active upper GI bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: Metoclopramide.UGIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No