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NCT Number: NCT07736911

Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy.

This study aims to evaluate the impact of a one-week discontinuation of long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) prior to Esophagogastroduodenoscopy on gastric preparation quality and the need for repeat esophagogastroduodenoscopy (EGD), in order to determine whether a one-week drug interruption constitutes an appropriate pre-procedural recommendation.

Recruiting

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Key information

Conditions

GLP-1

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Current use of GLP-1 receptor agonists (GLP-1 RAs) or tirzepatide (defined as discontinuation for no more than one week).
  • Continuous GLP-1 RA use for at least 4 weeks, or treatment at a near-maximal maintenance dose.
  • Scheduled to undergo esophagogastroduodenoscopy (EGD) for any indication.
  • Age between 18 and 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Provision of written informed consent.
  • Outpatient status.
  • If currently receiving medications that stimulate or inhibit gastrointestinal motility, these agents must be discontinued at least 3 days prior to EGD.

Exclusion criteria

  • • Severe comorbid conditions precluding safe EGD (e.g., unstable angina, recent myocardial infarction, heart failure, chronic respiratory disease, or bleeding diathesis).
  • History of prior upper gastrointestinal resection (stomach, intestine, or esophagus).
  • Any other condition deemed inappropriate by the treating physician.
  • Body mass index (BMI) > 40 kg/m².
  • Liver cirrhosis.
  • Parkinson's disease.
  • Dementia.
  • Use of tricyclic antidepressants or opioid medications for more than 3 months.

Treatment and study plan

Stop for 1 week

Drug

Stop for 1 week

GLP-1 non stop

Drug

GLP-1 non stop

Primary outcomes

  1. This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)

    Time frame: "From enrollment to the end of treatment at least 30 days

    After completion of all cleansing measures, cleanliness will be graded from 0 to 3 according to a predefined scoring system:

    • 0 = Completely obscured
    • 1 = Poor
    • 2 = Good
    • 3 = Excellent
    • This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy).

    Assessments on the Day of Upper Gastrointestinal Endoscopy (Day 0)

    Gastric preparation quality will be assessed using the PEACE system, and clinically significant lesions (CSLs) will be recorded as defined below:

    • Esophagus
    • Esophageal polyps
    • Erosive reflux esophagitis
    • Endoscopic suspicion of Barrett's esophagus
    • Esophageal ulcer
    • Esophageal tumor
    • Esophageal subepithelial lesion
    • Stomach
    • Gastric polyps
    • Gastric ulcer
    • Gastric tumor
    • Gastric subepithelial lesion
    • Duodenum
    • Duodenal polyps
    • Duodenal ulcer
    • Duodenal tumor
    • Duodenal subepithelial lesion Polyps will be defined according to the Paris classification types 0-I and 0-II.

Study contacts

Contact information is provided by the study sponsor or research team.

Kuan I Sung

CONTACT

[email protected]

+886928139643

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy: A Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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