MedDataX Logo

Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

NCT ID: NCT06167837

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

See the medical conditions and disease areas that this research is targeting or investigating.

Upper GI Bleeding

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

active upper GI bleeding EGD Gastric visualization Metoclopramide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metoclopramide group

Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD

Group Type EXPERIMENTAL

Metoclopramide Sulfone

Intervention Type DRUG

Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD

Placebo group

NSS 10 ml IV 30-60 min before EGD

Group Type PLACEBO_COMPARATOR

Normal Saline 10 mL Injection

Intervention Type DRUG

Normal saline 10 ml IV 30-60 minutes before EGD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoclopramide Sulfone

Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD

Intervention Type DRUG

Normal Saline 10 mL Injection

Normal saline 10 ml IV 30-60 minutes before EGD

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rapat Pittayanon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King Chulalongkorn memorial hospital

Bangkok, , Thailand

Site Status RECRUITING

King Chulalongkorn Memorial hospital

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thanrada Vimonsuntirungsri, MD

Role: CONTACT

Phone: +66853356240

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thanrada Vimonsuntirungsri, MD

Role: primary

Thanrada Vimonsuntirungsri

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Metoclopramide.UGIB

Identifier Type: -

Identifier Source: org_study_id