Using metoclopramide to improve gastric visualization in patients with 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 is testing if giving metoclopramide before an endoscopy can help doctors see better in patients who are actively bleeding in their upper digestive tract.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Trial ID | NCT06167837 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of metoclopramide in enhancing gastric visualization during endoscopy for patients experiencing active upper gastrointestinal bleeding (UGIB). It is a double-blinded, multicenter randomized controlled trial conducted across six hospitals in Thailand. Eligible adult patients with active UGIB will be randomly assigned to receive either intravenous metoclopramide or a placebo before undergoing endoscopy. The primary outcome is the adequacy of visualization assessed by objective endoscopic visualized scores, with secondary outcomes including various clinical metrics related to the procedure and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years and older who present with active upper GI bleeding and are scheduled for endoscopy within 12 hours.
Not a fit: Patients with known allergies to metoclopramide, prior gastric or duodenal surgery, or advanced HIV infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved endoscopic visualization and better management of patients with active upper GI bleeding.
How similar studies have performed: While there is limited data on the specific use of metoclopramide for this purpose, similar studies have explored adjunctive medications for improving endoscopic outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bangkok and 1 other locations
- King Chulalongkorn memorial hospital — Bangkok, Thailand (Recruiting)
- King Chulalongkorn Memorial hospital — Bangkok, Thailand (Not_yet_recruiting)
Study contacts
- Study coordinator: Thanrada Vimonsuntirungsri, MD
- Email: aa_choc@docchula.com
- Phone: +66853356240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.