Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1390 participants
INTERVENTIONAL
2026-02-28
2027-01-31
Brief Summary
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Adult patients (≥ 18 years) scheduled for elective or urgent gastroscopy are consecutively recruited. A gastric ultrasound is performed within one hour before the endoscopic procedure. The antral cross-sectional area is measured in standardized positions (supine and right lateral decubitus), and gastric volume is estimated using validated formulas. Gastric content is categorized into three grades (empty, low-risk liquid content, or high-risk/solid content).
During gastroscopy, complete aspiration of gastric contents is performed at the start of the procedure. The aspirated volume and qualitative characteristics (liquid vs. solid) are recorded, and the stomach is classified as empty, partially full, or full by the endoscopist.
The primary objective is to determine the accuracy of gastric ultrasound in identifying a full stomach. Secondary objectives include evaluating the qualitative agreement between ultrasound and gastroscopy, correlating estimated gastric volume with aspirated volume, and identifying an optimal ultrasound-based volume threshold predictive of a full stomach.
Approximately 1,390 patients will be enrolled over one year to obtain at least 139 "full stomach" cases, based on prevalence estimates and sample size calculations. Statistical analyses will include diagnostic performance metrics, Cohen's kappa, correlation tests, Bland-Altman plots, and ROC curve analysis.
Detailed Description
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Following the acquisition of written informed consent, baseline demographic and clinical data will be collected. Gastric ultrasound will then be performed using a portable ultrasound device equipped with a low-frequency curvilinear transducer. The patient will be positioned sequentially in the supine and right lateral decubitus positions, with the upper body inclined at 45°, to obtain sagittal views of the gastric antrum. Antral diameters (antero-posterior and cranio-caudal) will be measured in each position, and the cross-sectional antral area (CSA) will be calculated accordingly. The estimated gastric volume (EGV) will be derived using the validated formula proposed by Perlas et al. Gastric contents will be classified into three qualitative grades (Grade 0 to 2), enabling stratification of aspiration risk.
Within one hour of the ultrasound, a diagnostic gastroscopy will be performed by an experienced gastroenterologist, following routine clinical practice. Immediately upon endoscope insertion and prior to any irrigation, complete aspiration of gastric contents will be performed to allow accurate measurement of the intragastric volume. The contents will be assessed macroscopically for appearance (e.g., clear, cloudy, bilious, alimentary) and consistency (liquid or solid). The aspirated volume will be quantified using a calibrated, graduated container. Based on visual assessment, the stomach will be classified as empty, partially full, or full.
All collected data will be documented using standardized case report forms and entered into a secure, anonymized database for subsequent statistical analysis.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gastric Ultrasound and Gastroscopy
Single Group - Diagnostic Assessment
Gastric Ultrasound
All enrolled participants undergo a preoperative gastric ultrasound within one hour prior to the scheduled gastroscopy. The gastric antrum is measured in standardized positions, and estimated gastric volume is calculated.
Interventions
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Gastric Ultrasound
All enrolled participants undergo a preoperative gastric ultrasound within one hour prior to the scheduled gastroscopy. The gastric antrum is measured in standardized positions, and estimated gastric volume is calculated.
Eligibility Criteria
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Inclusion Criteria
* Indication for gastroscopy (scheduled or urgent), allowing complete aspiration of gastric contents
* Feasibility of performing gastric ultrasound within one hour prior to the endoscopic procedure
* Provision of written informed consent
Exclusion Criteria
* History of major gastric or esophageal surgery
* Known disorders of gastric emptying (e.g., gastroparesis, gastric outlet obstruction)
* Cognitive impairment or language barriers preventing understanding of the study protocol
* Active vomiting or technical impossibility to aspirate gastric contents
18 Years
ALL
No
Sponsors
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Hôpital Fribourgeois
OTHER
Responsible Party
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Abdouli Hadhami
Docteur, Cheffe de clinique Adjointe en anesthésiologie
Principal Investigators
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Hadhami Abdouli, Docteur
Role: PRINCIPAL_INVESTIGATOR
Hôpital Cantonal Fribourgeois
Locations
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HFR
Villars-sur-Glâne, Canton of Fribourg, Switzerland
Countries
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Central Contacts
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Facility Contacts
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hadhami Abdouli, Docteur
Role: primary
Role: backup
Other Identifiers
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GUSGA-2025
Identifier Type: -
Identifier Source: org_study_id