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

ConditionGLP-1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFu Jen Catholic University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLP-1 Stop for 1 week

    Drug

    Stop for 1 week

  • GLP-1 non stop

    Drug

    GLP-1 non stop

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: GLP-1 not stop for 1 weekPlacebo comparator 1 intervention
Group B: GLP-1 stop for 1 weekActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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: 1. Esophagus * Esophageal polyps * Erosive reflux esophagitis * Endoscopic suspicion of Barrett's esophagus * Esophageal ulcer * Esophageal tumor * Esophageal subepithelial lesion 2. Stomach * Gastric polyps * Gastric ulcer * Gastric tumor * Gastric subepithelial lesion 3. 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.

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

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

FJUHRecruiting24352, New Taipei City, TaiwanTaiwanTaiwan

Sponsors and contacts

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