Gastric Cancer StageNCT07104214
Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
An observational study of Gastric Cancer Stage and Esophageal Cancer, run by Zhejiang University at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage, Esophageal Cancer, Gastroparesis
- How many people
- 5,000 participants
- Where
- 3 sitesChina
- Study dates
- 3 Aug 2025to 31 May 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for sedated gastroscopy or sedated gastro-colonoscopy.
Who may be able to join
- Age ≥18 years.
- Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy.
- Participant provides informed consent.
Who cannot join
- Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h).
- Emergency endoscopic procedures
- Known pregnancy or lactation
- Subjects deemed ineligible by investigators
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, Dr, +8618616514088, diansansu@yahoo.com
Mingxia Su, Dr, ＋8613516713435
- Recruiting
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, 314000
Hongyuan Sui, +86 13050359876, sui_hongyuan@163.com
- Not yet recruiting
The Fifth Affiliated Hospital of Wenzhou Medical University
Lishui, Zhejiang, 323000
Zhilan Dou, 18857809608, 1024734445@qq.com
About this study
Official title: Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
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
- Medical subject headings
- Esophageal Neoplasms, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Incidence of Gastric Retention in Patients Undergoing Gastroscopy
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start3 Aug 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer StageStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
- Investigators
- Diansan Su, Dr, Study chair, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104214
- Sponsor's protocol ID
- ZJU2025B0611
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07104214
- Acronym / sponsor ID
- ZJU2025B0611
- Conditions
- Gastric Cancer Stage, Esophageal Cancer, Gastroparesis
- Keywords
- Gastric retention, Impaired gastric motility, Gastroparesis, Delayed gastric emptying
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for sedated gastroscopy or sedated gastro-colonoscopy.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy.
- Participant provides informed consent.
Key exclusion criteria (4 listed)
- Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h).
- Emergency endoscopic procedures
- Known pregnancy or lactation
- Subjects deemed ineligible by investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diansan Su, Dr study chair
First Affiliated Hospital of Zhejiang University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Stage and Esophageal Cancer, run by Zhejiang University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Chief Physician (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.