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

NCT07152756 | Not Yet Recruiting

• 1 other identifier: 2025K248
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 1

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)

Conditions

Gastric Retention

Keywords

Semaglutide; Gastric Retention; Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of gastric retention

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

  immediately after the esophagogastroduodenoscopy

Secondary Outcomes (2)

• Gastric Mucosal Visibility Score

  immediately after the esophagogastroduodenoscopy

• Rate of hypoxemia and aspiration events

  immediately after the esophagogastroduodenoscopy

Study Arms (2)

Exposure group

one-week discontinuation of semaglutide before EGD

Procedure: Esophagogastroduodenoscopy

non-exposure group

no semaglutide use before EGD

Procedure: Esophagogastroduodenoscopy

Interventions

Esophagogastroduodenoscopy PROCEDURE

Assess the gastric retention and the endoscopic mucosal visibility score during esophagogastroduodenoscopy

Exposure group; non-exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants undergoing sedated endoscopy who had discontinued semaglutide for one week prior to the procedure (with the last dose administered 8-14 days before EGD) were assigned to the exposure group, while those who had not used semaglutide were assigned to the non-exposure group.

You may qualify if:

• Subjects who have either: (i) been on long-term semaglutide therapy (≥4 weeks, any dosage) and discontinued use for one week prior to gastroscopy (with the last dose 8-14 days before the procedure), or(ii) never used semaglutide.
• For patients with diabetes mellitus (DM), HbA1c \< 9% to ensure adequate glycemic control.
• Age ≥ 18 years, with no restriction on sex.
• American Society of Anesthesiologists (ASA) physical status classification I-II.
• Fasting for at least 8 hours and no water intake for at least 4 hours before gastroscopy.
• Undergoing painless (sedated) endoscopy.

You may not qualify if:

• History of hiatal hernia or any previous gastric surgery (including gastrectomy, Roux-en-Y gastric bypass, etc.).
• Pregnancy.
• Medically unfit for gastrointestinal endoscopy.
• Deemed unsuitable for participation at the discretion of the investigators.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Interventions

Endoscopy, Digestive System

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Danian Ji, M.D.

  Huadong Hospital

  STUDY DIRECTOR

Central Study Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606; arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-18817870866; 18817870866@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of this study
• Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN (1)