Clinical trial NCT06167837: Metoclopramide for Gastric Visualization in Active Upper GI Bleeding
Official title: Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Upper GI Bleeding
Keywords: active upper GI bleeding
EGD
Gastric visualization
Metoclopramide
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with 'adequate visualization'
timeFrame: Through study completion, estimate 2 years
Secondary outcomes:
measure: The mean difference in EVS
timeFrame: Through study completion, estimate 2 years
measure: Duration of esophagogastroduodenoscopy
timeFrame: 10minutes to 2 hours
measure: Immediate hemostasis
timeFrame: Through study completion, estimate 2 years
measure: The need for a second look EGD within 72 hours after initial endoscopy
timeFrame: Up to 72 hours
measure: Number of unit of red blood cell transfusion during first 24 hours
timeFrame: Up to 24 hours
measure: Length of hospital stays
timeFrame: 1day - 30days
measure: 30-day rebleeding rate
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn memorial hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial hospital
Study officials:
References: