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Impact of a One-Week Discontinuation of Semaglutide on Gastric Retention and Endoscopic Mucosal Visibility Scores

Not yet recruiting
Conditions
Gastric Retention
Registration Number
NCT07152756
Lead Sponsor
Fudan University
Brief Summary

A prospective, single-center, observational study to compare the risk of gastric retention and endoscopic mucosal visibility between the exposure group (one-week discontinuation of semaglutide before EGD) and non-exposure group (no semaglutide use before EGD)

Detailed Description

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) mimic the action of endogenous GLP-1 hormones by activating GLP-1 receptors in the pancreas, brain, and gastrointestinal tract. This results in enhanced insulin secretion, suppressed glucagon release, delayed gastric emptying, and improved glycemic control and weight management in patients with type 2 diabetes. However, this pharmacological mechanism also increases the risk of gastric retention.

Multiple previous studies and recent meta-analyses have demonstrated that continued use of GLP-1RAs is associated with an elevated risk of gastric retention, which may lead to aspiration and significantly increase the risks associated with anesthesia. As a result, several recent expert consensus statements and clinical guidelines-including the 2023 ASA Expert Consensus and the 2025 ASGE Clinical Guidelines-recommend withholding weekly GLP-1RA agents for at least one week prior to procedures requiring anesthesia, regardless of dosage. For patients whose discontinuation period is less than one week, preoperative gastric ultrasound is advised to rule out gastric retention before proceeding with anesthesia; otherwise, anesthesia should be administered as for a "full stomach".

However, both the ASA consensus and ASGE guidelines acknowledge that clinical evidence supporting the effectiveness of a one-week GLP-1RA discontinuation in reducing gastric retention remains insufficient. A recent retrospective study reported that the risk of gastric retention remained significantly elevated even after one week of discontinuation compared to non-users. Only after a two-week discontinuation and in the absence of gastrointestinal symptoms such as bloating, nausea, or vomiting did the gastric retention risk return to normal levels.

Taken together, the current recommendation of a one-week discontinuation before anesthesia for weekly GLP-1RAs remains open to improvement and warrants further investigation through high-quality clinical studies to determine the optimal discontinuation interval.

In this study, we propose a single-center, prospective, observational study focusing on semaglutide, the most widely used weekly GLP-1RA. Individuals who have discontinued semaglutide for one week prior to undergoing painless endoscopy (with the last dose administered 8-14 days before the procedure) will be enrolled as the exposure group. Those who have not used any GLP-1RAs prior to the procedure will serve as the non-exposure group. The study aims to compare the risk of gastric retention and the endoscopic mucosal visibility score between the two groups, in order to explore the most appropriate semaglutide discontinuation interval before painless endoscopy.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
418
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of gastric retentionimmediately after the esophagogastroduodenoscopy

Gastric retention was defined as the presence of solid residues in the stomach or liquid retention exceeding 1.5 mL/kg

Secondary Outcome Measures
NameTimeMethod
Gastric Mucosal Visibility Scoreimmediately after the esophagogastroduodenoscopy
Rate of hypoxemia and aspiration eventsimmediately after the esophagogastroduodenoscopy

Trial Locations

Locations (1)

Huadong hospital, Fudan university

🇨🇳

Shanghai, Shanghai Municipality, China

Huadong hospital, Fudan university
🇨🇳Shanghai, Shanghai Municipality, China

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