Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastric Cancer Stage, Esophageal Cancer, Gastroparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
Overview
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.
Primary outcome measures
- Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcome measures (3)
- Correlation between gastric residual volume (GRV) grading and Gastroparesis Cardinal Symptom Index (GCSI) scores (range: 0-20, higher scores indicate worse symptoms) [Time frame: 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) [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
- Incidence of Gastric Retention in Patients Undergoing Gastroscopy [Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 3 centers
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- The Second Affiliated Hospital of Jiaxing University — Jiaxing
- The Fifth Affiliated Hospital of Wenzhou Medical University — Lishui
Identifiers
NCT: NCT07104214 · ZJU2025B0611