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

NCT ID: NCT07104214

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Stage Esophageal Cancer Gastroparesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Diansan Su

Chief Physician,Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diansan Su, Dr

Role: STUDY_CHAIR

Zhejiang University

Locations

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The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer hospital

Hangzhou, Zhejiang, China

Site Status

The Fourth Affiliated Hospital, Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Diansan Su, Chief Physician

Role: CONTACT

+8618616514088

Mingxia Xu

Role: CONTACT

+8613516713435

Facility Contacts

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Diansan Su, Dr

Role: primary

+8618616514088

Mingxia Su, Dr

Role: backup

+8613516713435

Zihan Mu, Dr

Role: primary

+8617280781160

Jian Guo, Dr

Role: primary

+8613858116560

Other Identifiers

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ZJU2025B0611

Identifier Type: -

Identifier Source: org_study_id

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