Risk prediction for gastric retention during sedated gastroscopy
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
This study will test a simple grading system and prediction model to see if clinicians can identify which adults are likely to have significant stomach contents before sedated gastroscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 3 sites (Hangzhou, Zhejiang and 2 other locations) |
| Trial ID | NCT07104214 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will establish and validate a standardized gastric residual volume (GRV) grading system during elective sedated upper endoscopy. Investigators will record endoscopic findings of retained gastric contents and collect demographic, comorbidity, and medication history data. Those data will be used to build and validate a risk prediction model for gastric retention. The aim is a simplified endoscopy-based tool to help guide fasting and anesthesia planning.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy and can provide informed consent are the ideal candidates.
Not a fit: Patients undergoing emergency endoscopy, those with acute upper GI bleeding, pregnant or lactating people, and children are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the tool could help clinicians identify patients at higher risk of gastric retention so they can tailor fasting instructions and anesthesia plans to reduce aspiration risk.
How similar studies have performed: Related approaches such as gastric ultrasound have shown promise in estimating gastric volume, but a standardized endoscopy-based GRV grading and prediction model is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang and 2 other locations
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- The Second Affiliated Hospital of Jiaxing University — Jiaxing, Zhejiang, China (Recruiting)
- The Fifth Affiliated Hospital of Wenzhou Medical University — Lishui, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Diansan Su, Chief Physician
- Email: diansansu@yahoo.com
- Phone: +8618616514088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.