Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
GLP-1 stop for 1 week
GLP-1 stop for 1 week
Intervention: GLP-1 Stop for 1 week (Drug)
GLP-1 not stop for 1 week
GLP-1 not stoping and under persistent use
Intervention: GLP-1 non stop (Drug)
Outcomes
Primary Outcomes
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: 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.
Secondary Outcomes
No secondary outcomes reported