Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy

Zhejiang University

Status: Not yet enrolling

Conditions: Gastroparesis; Esophageal Cancer; Gastric Cancer Stage

Study type: Observational

Funder types: Other

Identifiers

NCT07104214

ZJU2025B0611

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

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.