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

Not yet recruiting

• Conditions: Gastric Cancer Stage; Esophageal Cancer; Gastroparesis

• Registration Number: NCT07104214
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-08-11
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	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 Outcome Measures

Name	Time	Method
Correlation between gastric residual volume (GRV) grading and Gastroparesis Cardinal Symptom Index (GCSI) scores (range: 0-20, higher scores indicate worse symptoms)	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	The standardized Gastroparesis Cardinal Symptom Index (GCSI) was used to quantify the following core symptoms: Nausea (frequency \& intensity): 0 (none) to 5 (severe, persistent daily).; Vomiting (episode frequency): 0 (none) to 5 (≥3 times/day).; Postprandial fullness (duration): 0 (none) to 5 (\>4 hours).; Early satiety (food intake limitation): 0 (normal eating) to 5 (eating \<25% of usual amount).; Statistical Analysis: The correlation between GRV grades (0-4) and the total GCSI score was assessed using Spearman's rank correlation coefficient.
Development and validation of a simplified clinical scoring system for gastric retention risk stratification (score range: 0-10, higher scores indicate higher risk)	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	Development Method: Based on multivariate logistic regression results, independent predictive factors (e.g., diabetes, GLP-1 medication use) were converted into a clinical scoring system (e.g., 1-2 points per factor).; Validation Process: Discrimination: The AUC (area under the curve) of the scoring system was calculated in the validation cohort (target \>0.7).; Calibration: The Hosmer-Lemeshow test was used to assess the agreement between predicted and observed risks.; Example Scoring Range: 0-3 points: Low risk、4-6 points: Moderate risk、7-10 points: High risk.
Incidence of Gastric Retention in Patients Undergoing Gastroscopy	Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Trial Locations

Locations (3)

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China

The Fourth Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Yiwu, Zhejiang, China