Clinical trial · Observational
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Gastric retention not only compromises the quality of endoscopic examination but also significantly increases the risk of reflux and aspiration in sedated patients. Aspiration of gastric contents represents a critical anesthesia-related complication during the perioperative period, carrying substantial implications for anesthetic management. With the growing volume of sedated gastroscopy procedures, predicting gastric retention has become an urgent clinical priority. This prospective study aims to establish a standardized gastric residual volume (GRV) grading system to evaluate both the volume of retained gastric contents and its contributing factors in patients undergoing upper gastrointestinal endoscopy. We will systematically assess the impact of demographic characteristics, comorbidities, and medication history on gastric emptying function. This study will facilitate establishment of an endoscopy-based simplified assessment system for gastric retention.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer Stage | — | UNRESOLVED | — |
| Gastroparesis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Model Development Cohort, External Validation Cohort
- description
- Model Development Cohort Definition: 3,000 patients used to identify risk factors and build the prediction mode. External Validation Cohort Definition: 2,000 independent patients from multiple centers to test the model's accuracy.
Primary outcomes (1)
- measure
- Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system
- timeFrame
- Patients will be followed for the duration of hospital stay, an expected average about 2 hours
- description
- Measurement Tool: Standardized endoscopic gastric residual volume grading system : Grade 0:Stomach completely clean, no visible residue; Grade 1:Small amount of clear liquid (\<1.5 mL/kg or \<100 mL), no solid components; Grade 2:Liquid ≥1.5 mL/kg (or ≥100 mL) or small solid fragments (\<5 mm); Grade 3:Large amount of liquid (\>200 mL) or significant solid residue (≥5 mm fragments) Grade 4:Visible undigested food chunks or intact food pieces Data Collection: Two physicians independently assessed gastric residue (liquid/solid), measuring volume using a graduated suction bottle, with video recordings archived for third-party review. Statistical Methods: The incidence (%) of gastric retention (≥Grade 2) was calculated. Multivariate logistic regression analyzed risk factors, and ROC curves evaluated the model's predictive performance (AUC).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy. * Participant provides informed consent. Exclusion Criteria: * Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h). * Emergency endoscopic procedures * Known pregnancy or lactation * Subjects deemed ineligible by investigators
References
Publications (0)
Data not yet available