Gastric EmptyingNCT07360262
Gastric Emptying Recovery After GLP-1 RA Cessation
An observational study of Gastric Emptying and Gastroparesis, run by Wonkwang University Hospital at 2 sites in South Korea.
Trial summary
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can delay gastric emptying and may increase residual gastric contents before general anesthesia. Current perioperative recommendations for withholding GLP-1 RAs (e.g., a fixed 7-day discontinuation for weekly agents) are largely consensus-based, and it is unclear… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Emptying, Gastroparesis, Preoperative Care
- What is being tested?
- Preoperative gastric ultrasound
- How many people
- 186 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Nov 2025to 12 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients receiving GLP-1 receptor agonists who were scheduled for elective surgery under general anesthesia at a tertiary academic hospital and underwent preoperative point-of-care gastric ultrasound immediately prior to induction of anesthesia.
Who may be able to join
- Adults aged ≥18 years
- Receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
- Scheduled for elective surgery under general anesthesia
- Able to provide written informed consent
Who cannot join
- Prior gastric or esophageal surgery
- Known gastroparesis
- Severe gastroesophageal reflux disease
- Emergency surgery
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Wonkwang University Hospital
Iksan, Jeollabuk-do, 54538
Wonkwang University School of Medicine Hospital
Iksan, Jeollabuk-do, 54538
About this study
Official title: Time-dependent Recovery of Gastric Emptying After Cessation of Glucagon-like Peptide-1 Receptor Agonists: a Prospective Observational Gastric Ultrasound Study
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can delay gastric emptying and may increase residual gastric contents before general anesthesia. Current perioperative recommendations for withholding GLP-1 RAs (e.g., a fixed 7-day discontinuation for weekly agents) are largely consensus-based, and it is unclear whether gastric emptying normalizes abruptly after a single threshold interval. This prospective observational cohort study will evaluate how preoperative residual gastric content changes with increasing time since the last GLP-1 RA dose, using point-of-care gastric ultrasound performed immediately before induction of anesthesia. Time since last dose will be analyzed as a continuous exposure and across prespecified intervals (≤3 days, 4-7 days, ≥8 days). The primary outcome is ultrasound-estimated gastric volume normalized to body weight (mL/kg), derived from antral cross-sectional area. Secondary outcomes include the presence of a "high-risk stomach" based on gastric volume criteria and qualitative ultrasound findings. The study will also assess whether body mass index modifies the relationship between cessation interval and gastric volume, thereby supporting individualized perioperative risk assessment.
Read the detailed description
Study design and setting: This is a prospective observational cohort study conducted at a tertiary academic hospital to evaluate gastric emptying recovery after cessation of GLP-1 receptor agonists. Adult patients (≥18 years) receiving GLP-1 RAs and scheduled for elective surgery under general anesthesia will be enrolled consecutively to minimize selection bias. Prespecified exclusions include prior gastric or esophageal surgery, known gastroparesis, severe gastroesophageal reflux disease, emergency surgery, pregnancy, and inability to provide informed consent.
Exposure (no intervention assignment): The study does not assign or modify GLP-1 RA therapy. Time since the last GLP-1 RA dose will be recorded in days using patient report and medical records and analyzed both as a continuous variable and as prespecified categories (≤3 days, 4-7 days, ≥8 days). Information on GLP-1 RA formulation (weekly vs daily) and dose equivalence may be collected for sensitivity analyses. Potential confounders such as fasting duration and type of surgery will be recorded.
Gastric ultrasound procedures: Point-of-care gastric ultrasound will be performed immediately before induction of anesthesia using a standardized protocol by trained consultant anesthesiologists. The gastric antrum will be assessed in the supine and right lateral decubitus positions. Qualitative assessment of gastric content will be documented, and quantitative measurements of antral cross-sectional area will be used to estimate gastric volume.
Outcomes: The primary outcome is estimated gastric volume normalized to body weight (mL/kg). Secondary outcomes include the presence of a high-risk stomach, as defined by prespecified gastric volume criteria and qualitative ultrasound findings. Additional exploratory analyses will evaluate whether body mass index modifies the association between cessation interval and gastric volume and whether patient-reported gastrointestinal symptoms correlate with ultrasound findings.
Analysis overview: Associations between time since the last GLP-1 RA dose and gastric ultrasound outcomes will be assessed using prespecified regression models adjusted for relevant covariates (e.g., age, sex, BMI, diabetes status, fasting duration, and symptom measures). The interaction between BMI and cessation interval will be evaluated to characterize potential effect modification.
- Conditions
- Gastric Emptying, Gastroparesis, Preoperative Care
- Being tested
- Preoperative gastric ultrasound
- Keywords
- GLP-1 receptor agonist, GLP-1 RA cessation / withholding interval, Point-of-care ultrasound / POCUS, Gastric ultrasound, Residual gastric volume
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative gastric ultrasoundOther
Also called Point-of-care gastric ultrasound (Gastric POCUS)
Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area. The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RA cessation ≤3 days | Participants using GLP-1 receptor agonists whose last dose was taken ≤3 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). Receives: Other: Preoperative gastric ultrasound | |
| GLP-1 RA cessation 4-7 days | Participants using GLP-1 receptor agonists whose last dose was taken 4-7 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). Receives: Other: Preoperative gastric ultrasound | |
| GLP-1 RA cessation ≥8 days | Participants using GLP-1 receptor agonists whose last dose was taken ≥8 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). Receives: Other: Preoperative gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-estimated gastric volume (mL/kg)
Estimated gastric volume normalized to body weight (mL/kg) was calculated from the gastric antral cross-sectional area measured by preoperative point-of-care ultrasound using validated equations.
Measured: Immediately preoperatively (just before induction of anesthesia)
Secondary outcomes (2)
Perlas grade of gastric content (0-2)
Qualitative gastric ultrasound grading of gastric content was recorded using the Perlas classification (Grade 0, 1, or 2) based on antral appearance in the supine and right lateral decubitus positions.
Measured: Immediately preoperatively (just before induction of anesthesia)
Antral cross-sectional area (CSA, cm²)
Gastric antral cross-sectional area (cm²) was measured by preoperative ultrasound and used to estimate gastric volume.
Measured: Immediately preoperatively (just before induction of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Nov 2025
- Primary completion10 Dec 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D.,Ph.D, Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360262
- Sponsor's protocol ID
- Wonkwang UH 23
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-dependent Recovery of Gastric Emptying After Cessation of Glucagon-like Peptide-1 Receptor Agonists: a Prospective Observational Gastric Ultrasound Study
- ClinicalTrials.gov ID
- NCT07360262
- Acronym / sponsor ID
- Wonkwang UH 23
- Conditions
- Gastric Emptying, Gastroparesis, Preoperative Care
- Keywords
- GLP-1 receptor agonist, GLP-1 RA cessation / withholding interval, Point-of-care ultrasound / POCUS, Gastric ultrasound, Residual gastric volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 22 Jan 2026 (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.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can delay gastric emptying and may increase residual gastric contents before general anesthesia. Current perioperative recommendations for withholding GLP-1 RAs (e.g., a fixed 7-day discontinuation for weekly agents) are largely consensus-based, and it is unclear whether gastric emptying normalizes abruptly after a single threshold interval. This prospective observational cohort study will evaluate how preoperative residual gastric content changes with increasing time since the last GLP-1 RA dose, using point-of-care gastric ultrasound performed immediately before induction of anesthesia. Time since last dose will be analyzed as a continuous exposure and across prespecified intervals (≤3 days, 4-7 days, ≥8 days). The primary outcome is ultrasound-estimated gastric volume normalized to body weight (mL/kg), derived from antral cross-sectional area. Secondary outcomes include the presence of a "high-risk stomach" based on gastric volume criteria and qualitative ultrasound findings. The study will also assess whether body mass index modifies the relationship between cessation interval and gastric volume, thereby supporting individualized perioperative risk assessment.
Detailed description
Study design and setting: This is a prospective observational cohort study conducted at a tertiary academic hospital to evaluate gastric emptying recovery after cessation of GLP-1 receptor agonists. Adult patients (≥18 years) receiving GLP-1 RAs and scheduled for elective surgery under general anesthesia will be enrolled consecutively to minimize selection bias. Prespecified exclusions include prior gastric or esophageal surgery, known gastroparesis, severe gastroesophageal reflux disease, emergency surgery, pregnancy, and inability to provide informed consent.
Exposure (no intervention assignment): The study does not assign or modify GLP-1 RA therapy. Time since the last GLP-1 RA dose will be recorded in days using patient report and medical records and analyzed both as a continuous variable and as prespecified categories (≤3 days, 4-7 days, ≥8 days). Information on GLP-1 RA formulation (weekly vs daily) and dose equivalence may be collected for sensitivity analyses. Potential confounders such as fasting duration and type of surgery will be recorded.
Gastric ultrasound procedures: Point-of-care gastric ultrasound will be performed immediately before induction of anesthesia using a standardized protocol by trained consultant anesthesiologists. The gastric antrum will be assessed in the supine and right lateral decubitus positions. Qualitative assessment of gastric content will be documented, and quantitative measurements of antral cross-sectional area will be used to estimate gastric volume.
Outcomes: The primary outcome is estimated gastric volume normalized to body weight (mL/kg). Secondary outcomes include the presence of a high-risk stomach, as defined by prespecified gastric volume criteria and qualitative ultrasound findings. Additional exploratory analyses will evaluate whether body mass index modifies the association between cessation interval and gastric volume and whether patient-reported gastrointestinal symptoms correlate with ultrasound findings.
Analysis overview: Associations between time since the last GLP-1 RA dose and gastric ultrasound outcomes will be assessed using prespecified regression models adjusted for relevant covariates (e.g., age, sex, BMI, diabetes status, fasting duration, and symptom measures). The interaction between BMI and cessation interval will be evaluated to characterize potential effect modification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RA cessation ≤3 days | – | Other: Preoperative gastric ultrasoundParticipants using GLP-1 receptor agonists whose last dose was taken ≤3 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). |
| GLP-1 RA cessation 4-7 days | – | Other: Preoperative gastric ultrasoundParticipants using GLP-1 receptor agonists whose last dose was taken 4-7 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). |
| GLP-1 RA cessation ≥8 days | – | Other: Preoperative gastric ultrasoundParticipants using GLP-1 receptor agonists whose last dose was taken ≥8 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients receiving GLP-1 receptor agonists who were scheduled for elective surgery under general anesthesia at a tertiary academic hospital and underwent preoperative point-of-care gastric ultrasound immediately prior to induction of anesthesia.
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
- Scheduled for elective surgery under general anesthesia
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- Prior gastric or esophageal surgery
- Known gastroparesis
- Severe gastroesophageal reflux disease
- Emergency surgery
- Pregnancy
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 |
|---|---|---|
| Preoperative gastric ultrasoundAlso: Point-of-care gastric ultrasound (Gastric POCUS)Preoperative point-of-care gastric ultrasound was performed immediately prior to induction of anesthesia to assess qualitative gastric content and to estimate gastric volume from antral cross-sectional area. The procedure was observational and was applied to all cohorts; no study-assigned treatment was administered or modified. | Other | GLP-1 RA cessation 4-7 days, GLP-1 RA cessation ≤3 days, GLP-1 RA cessation ≥8 days |
Primary outcome
Ultrasound-estimated gastric volume (mL/kg)
Time frame: Immediately preoperatively (just before induction of anesthesia)
Estimated gastric volume normalized to body weight (mL/kg) was calculated from the gastric antral cross-sectional area measured by preoperative point-of-care ultrasound using validated equations.
2 secondary outcomes
Perlas grade of gastric content (0-2)
Time frame: Immediately preoperatively (just before induction of anesthesia)
Antral cross-sectional area (CSA, cm²)
Time frame: Immediately preoperatively (just before induction of anesthesia)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Related trials for Gastric Emptying
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
Not yet recruitingObservational study
Effects of Tirzepatide on Gut Microbiota and Gastrointestinal Function After Drug Withdrawal in Obese Patients
Obesity / Overweight
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Not yet recruiting
Gastric Emptying After a Yoghurt Breakfast in Children: a Pilot Study
Preoperative Fasting
Recruiting
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Depression, Epilepsy
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. This study is not recruiting at the moment.
Cheol Lee, M.D.,Ph.D principal investigator
Wonkwang University Hospital
2 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 Emptying and Gastroparesis, run by Wonkwang University Hospital at 2 sites in South Korea.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound-estimated gastric volume (mL/kg) (time frame: Immediately preoperatively (just before induction of anesthesia)). 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 23 Jan 2026.