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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model Development Cohort, External Validation Cohort | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system | 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). | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between gastric residual volume (GRV) grading and Gastroparesis Cardinal Symptom Index (GCSI) scores (range: 0-20, higher scores indicate worse symptoms) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and risk factors of anesthesia-related adverse events in patients undergoing sedated gastroscopy | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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Adults scheduled for sedated gastroscopy or sedated gastro-colonoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Chief Physician | Contact | +8618616514088 | diansansu@yahoo.com | |
| Mingxia Xu | Contact | +8613516713435 | xumingxia@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, Dr | Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Development and validation of a simplified clinical scoring system for gastric retention risk stratification (score range: 0-10, higher scores indicate higher risk) | 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. | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| Incidence of Gastric Retention in Patients Undergoing Gastroscopy | Patients will be followed for the duration of hospital stay, an expected average about 2 hours |
| The Second Affiliated Hospital of Jiaxing University | Recruiting | Jiaxing | Zhejiang | 314000 | China |
|
| The Fifth Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |