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

NCT07104214 | Recruiting

• 1 other identifier: ZJU2025B0611
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastric Cancer Stage; Esophageal Cancer; Gastroparesis

Keywords

Gastric retention; Impaired gastric motility; Gastroparesis; Delayed gastric emptying

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• Incidence of Gastric Retention in Patients Undergoing Gastroscopy

  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

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled for sedated gastroscopy or sedated gastro-colonoscopy.

You may qualify if:

• Age ≥18 years.
• Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy.
• Participant provides informed consent.

You may not qualify if:

• Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h).
• Emergency endoscopic procedures
• Known pregnancy or lactation
• Subjects deemed ineligible by investigators

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (3)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

The Second Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

RECRUITING

The Fifth Affiliated Hospital of Wenzhou Medical University

Lishui, Zhejiang, 323000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Gastroparesis

Condition Hierarchy (Ancestors)

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

Study Officials

• Diansan Su, Dr

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Diansan Su, Chief Physician

CONTACT

+8618616514088; diansansu@yahoo.com

Mingxia Xu

CONTACT

+8613516713435; xumingxia@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Researcher

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 5, 2025
• Study Start: August 3, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)