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NCT Number: NCT07749300

Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding

Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures.

This study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose.

Researchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols.

The primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena.
  • Planned urgent upper gastrointestinal endoscopy within 24 hours.

Exclusion criteria

  • Known gastric outlet obstruction.
  • Previous gastric surgery.
  • Pregnancy or lactation.
  • Allergy to Trimebutine Maleate.
  • Chronic use of prokinetic medications.

Treatment and study plan

Trimebutine Maleate

Drug

50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.

Placebo

Other

A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.

Primary outcomes

  1. Total Gastric Visualization Score

    Time frame: 60 to 90 minutes post-intervention

    Gastric visualization will be assessed by the endoscopist across five anatomical areas: the fundus, upper body, lower body, antrum, and duodenum. Each area is evaluated using a 4-point scale: 0 (large amount of blood/clots obscuring vision), 1 (moderate blood requiring suction), 2 (small amount of blood with adequate visualization), and 3 (excellent visualization). The scores from all five areas are summed to create a Total Gastric Visualization Score ranging from 0 to 15, with higher scores indicating better visualization.

Secondary outcomes

  1. Identification Rate of Bleeding Source

    Time frame: 60 to 90 minutes post-intervention

    Percentage of participants in whom the specific anatomical source of upper gastrointestinal bleeding is successfully identified during the endoscopy procedure.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Trimebutine Maleate in Enhancing Endoscopic Gastric Visualization in Patients With Acute Upper Gastrointestinal Bleeding: A Double-Blind Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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