Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
研究组 & 干预措施
GLP-1 stop for 1 week
GLP-1 stop for 1 week
干预措施: GLP-1 Stop for 1 week (Drug)
GLP-1 not stop for 1 week
GLP-1 not stoping and under persistent use
干预措施: GLP-1 non stop (Drug)
结局指标
主要结局
This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)
时间窗: "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.
次要结局
未报告次要终点