Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

King Chulalongkorn Memorial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Upper GI Bleeding

Treatments: Drug: Metoclopramide Sulfone; Drug: Normal Saline 10 mL Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06167837

Metoclopramide.UGIB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Metoclopramide group

Experimental group

Description:

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

Treatment:

Drug: Metoclopramide Sulfone

Placebo group

Placebo Comparator group

Description:

NSS 10 ml IV 30-60 min before EGD

Treatment:

Drug: Normal Saline 10 mL Injection