Gastric Ultrasound Versus Gastroscopic Aspiration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital Fribourgeois
About this trial
This is a prospective, single-center observational study conducted at the Fribourg Cantonal Hospital to evaluate the diagnostic performance of preoperative gastric ultrasound in determining gastric content and volume. Upper gastrointestinal endoscopy with complete suction of gastric contents serves as the reference standard.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥ 18 years
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
Disqualifiers
Pregnancy
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
Trial design
Design model
Single group
Treatments tested in this trial
Gastric Ultrasound
Diagnostic testAll 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.
Treatment groups
1,390 Participants
are divided into 1 treatment groupGroup A: Gastric Ultrasound and GastroscopyOther 1 intervention
Trial outcomes
Primary outcomes
1
the diagnostic accuracy of gastric ultrasound in identifying a full stomach, using gastroscopy with aspiration as the reference standard.
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of preoperative gastric ultrasound in identifying a full stomach, compared to gastroscopy with complete aspiration of gastric contents. Gastric content is classified as empty, low-risk liquid content, or high-risk/solid content.
Time frame
Within 1 hour prior to gastroscopySecondary outcomes
1
Correlation coefficient between ultrasound-estimated gastric volume and aspirated gastric content volume during gastroscopy
Gastric volume is estimated by preoperative ultrasound and compared with the volume of gastric content aspirated during gastroscopy. The Pearson or Spearman correlation coefficient is calculated depending on data distribution.
Time frame
Within 1 hour prior to gastroscopy2
Cohen's kappa coefficient for agreement between ultrasound and gastroscopy regarding gastric content nature
Agreement between gastric ultrasound and gastroscopy for classification of gastric content nature (clear liquid, turbid liquid, solid) is assessed using Cohen's kappa coefficient.
Time frame
Within 1 hour prior to gastroscopy3
Optimal estimated gastric volume (EGV) threshold for predicting a full stomach
Determination of the optimal threshold of estimated gastric volume (EGV) measured by preoperative ultrasound for predicting a full stomach, using receiver operating characteristic (ROC) curve analysis. Sensitivity, specificity, and area under the ROC curve (AUC) will be calculated.
Time frame
Within 1 hour prior to gastroscopySponsors and contacts
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Source ClinicalTrials.gov
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