Gastric RetentionNCT07276763
Impact of Discontinuing GLP-1 Receptor Agonists for Two Weeks Prior to Upper Endoscopy on the Risk of Gastric Retention
An observational study of Gastric Retention, run by Fudan University at 1 site in China.
Trial summary
A retrospective observational study to explore the impact of discontinuing GLP-1 receptor agonists for two weeks prior to upper endoscopy on the risk of gastric retention Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Retention
- How many people
- 16,509 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 15 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent elective EGD at Huadong Hospital and had complete retrievable information on medication use, medical records, and endoscopy reports
Who may be able to join
- Undergoing elective upper endoscopy
- Complete clinical information available, including endoscopy report, age, sex, BMI, history of diabetes, prior gastric surgery, and gastrointestinal symptom
Who cannot join
- Presence of upper gastrointestinal malignancy or obstruction
- History of gastric surgery (including ESD, gastrectomy, gastric bypass, etc.)
- Emergency endoscopy or non-elective procedures
- Missing key clinical information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Impact of Discontinuing GLP-1 Receptor Agonists for Two Weeks Prior to Upper Endoscopy on the Risk of Gastric Retention: A Retrospective Observational Study
A retrospective observational study to explore the impact of discontinuing GLP-1 receptor agonists for two weeks prior to upper endoscopy on the risk of gastric retention
Read the detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1RAs), including semaglutide, liraglutide, and dulaglutide, are widely used for the management of type 2 diabetes and obesity. These agents improve glycemic control in part by delaying gastric emptying, but this pharmacologic effect may increase the risk of retained gastric contents (RGC) and aspiration during anesthesia or sedation. In 2023, the American Society of Anesthesiologists (ASA) and the American Society for Gastrointestinal Endoscopy (ASGE) issued recommendations to withhold GLP-1RAs before procedures; however, the optimal discontinuation interval remains uncertain.
Using the electronic medical record system of Huadong Hospital, this retrospective study analyzed patients who underwent upper endoscopy between August 2023 and May 2025 to examine the association between different GLP-1RA exposure patterns and the risk of RGC, providing evidence to inform optimization of pre-procedural discontinuation strategies.
- Conditions
- Gastric Retention
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Glucagon-like peptide-1 receptor agonists, Gastric Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| No GLP-1RA group | Patients with no prescription record of GLP-1RAs, or whose most recent prescription was more than 3 months before the EGD Receives: Other: No Intervention: Observational Cohort | |
| GLP-1RA Continued group | Patients who met both of the following criteria:
1. Continued use of a GLP-1RA (e.g., semaglutide or dulaglutide) within 3 months prior to EGD;
2. Underwent painless EGD before August 2024, when our institution had not yet implemented restrictions on GLP-1RA use for painless endoscopy. Receives: Other: No Intervention: Observational Cohort | |
| GLP-1RA Held 2 Weeks group | Patients who met both of the following criteria:
1. Continued use of a GLP-1RA (e.g., semaglutide or dulaglutide) within 3 months prior to EGD;
2. Underwent painless EGD after August 2024, when institutional policy mandated that patients discontinue GLP-1RAs for at least 14 days prior to painless EGD. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of gastric retention
Measured: Immediately at study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric RetentionStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Retrospective
- Enrolment
- 16,509 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Danian Ji, M.D., Study director, Huadong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276763
- Sponsor's protocol ID
- 2025K368
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Discontinuing GLP-1 Receptor Agonists for Two Weeks Prior to Upper Endoscopy on the Risk of Gastric Retention: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07276763
- Acronym / sponsor ID
- 2025K368
- Conditions
- Gastric Retention
- Keywords
- Glucagon-like peptide-1 receptor agonists, Gastric Retention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 16,509 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 11 Dec 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.
A retrospective observational study to explore the impact of discontinuing GLP-1 receptor agonists for two weeks prior to upper endoscopy on the risk of gastric retention
Detailed description
Glucagon-like peptide-1 receptor agonists (GLP-1RAs), including semaglutide, liraglutide, and dulaglutide, are widely used for the management of type 2 diabetes and obesity. These agents improve glycemic control in part by delaying gastric emptying, but this pharmacologic effect may increase the risk of retained gastric contents (RGC) and aspiration during anesthesia or sedation. In 2023, the American Society of Anesthesiologists (ASA) and the American Society for Gastrointestinal Endoscopy (ASGE) issued recommendations to withhold GLP-1RAs before procedures; however, the optimal discontinuation interval remains uncertain.
Using the electronic medical record system of Huadong Hospital, this retrospective study analyzed patients who underwent upper endoscopy between August 2023 and May 2025 to examine the association between different GLP-1RA exposure patterns and the risk of RGC, providing evidence to inform optimization of pre-procedural discontinuation strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No GLP-1RA group | – | Other: No Intervention: Observational CohortPatients with no prescription record of GLP-1RAs, or whose most recent prescription was more than 3 months before the EGD |
| GLP-1RA Continued group | – | Other: No Intervention: Observational CohortPatients who met both of the following criteria: 1. Continued use of a GLP-1RA (e.g., semaglutide or dulaglutide) within 3 months prior to EGD; 2. Underwent painless EGD before August 2024, when our institution had not yet implemented restrictions on GLP-1RA use for painless endoscopy. |
| GLP-1RA Held 2 Weeks group | – | Other: No Intervention: Observational CohortPatients who met both of the following criteria: 1. Continued use of a GLP-1RA (e.g., semaglutide or dulaglutide) within 3 months prior to EGD; 2. Underwent painless EGD after August 2024, when institutional policy mandated that patients discontinue GLP-1RAs for at least 14 days prior to painless EGD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent elective EGD at Huadong Hospital and had complete retrievable information on medication use, medical records, and endoscopy reports
Key inclusion criteria (2 listed)
- Undergoing elective upper endoscopy
- Complete clinical information available, including endoscopy report, age, sex, BMI, history of diabetes, prior gastric surgery, and gastrointestinal symptom
Key exclusion criteria (4 listed)
- Presence of upper gastrointestinal malignancy or obstruction
- History of gastric surgery (including ESD, gastrectomy, gastric bypass, etc.)
- Emergency endoscopy or non-elective procedures
- Missing key clinical information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | GLP-1RA Continued group, GLP-1RA Held 2 Weeks group, No GLP-1RA group |
Primary outcome
Proportion of gastric retention
Time frame: Immediately at study initiation
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 Dec 2025.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
Danian Ji, M.D. study director
Huadong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Retention, run by Fudan University at 1 site 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 2 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: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Danian Ji, M.D. (+86-18019094606, arctg4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of gastric retention (time frame: Immediately at study initiation). 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 Dec 2025.