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NCT Number: NCT07104214

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

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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Key information

Conditions

Gastric Cancer Stage Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastroparesis Head and Neck Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

Other outcomes

  1. Incidence and risk factors of anesthesia-related adverse events in patients undergoing sedated gastroscopy

    Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, Chief Physician

CONTACT

[email protected]

+8618616514088

Mingxia Xu

CONTACT

[email protected]

+8613516713435

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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