Actively Recruiting
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
Led by Zhejiang University · Updated on 2026-03-11
5000
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating gastric retention in patients undergoing sedated gastroscopy to improve safety and examination quality. This observational study aims to develop and validate a standardized gastric residual volume (GRV) grading system to measure the volume of retained stomach contents. It also investigates how demographic factors, comorbidities, and medication history affect gastric emptying. The goal is to create a simple, endoscopy-based assessment tool for gastric retention risk. The study involves two groups: a model development cohort of 3,000 patients to identify risk factors and build a prediction model, and an external validation cohort of 2,000 patients from multiple centers to test the model's accuracy. Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy will be included. There is no intervention; instead, participants undergo routine endoscopic examination during which gastric residual volume is graded. Participants will be followed during their hospital stay, typically about 2 hours, while researchers measure delayed gastric emptying using the GRV grading system. Secondary measures include correlation of GRV with symptom scores and development of a simplified risk scoring system. Data collection focuses on patient demographics, comorbidities, medications, and gastroscopy findings. Safety and outcome data are recorded during this short observation period.
CONDITIONS
Brief Title
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy
- Provides informed consent to participate
You will not qualify if you...
- Acute upper gastrointestinal bleeding within 24 hours (vomiting blood, black stools, or confirmed bleeding)
- Emergency endoscopic procedures
- Pregnant or breastfeeding
- Considered ineligible by study investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to procedure
Duration - Approximately the duration of the hospital stay (about 2 hours)
Participants undergo sedated gastroscopy or sedated gastro-colonoscopy during which gastric residual volume is assessed.
1 visit (in-person) on procedure day
Duration - Approximately 2 hours during hospital stay
Participants are followed for the duration of their hospital stay to assess gastric retention and related symptoms.
Monitoring during procedure visit
Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China, 314000
Actively Recruiting
3
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
Research Team
D
Diansan Su, Chief Physician
M
Mingxia Xu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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