NCT06533527已完成4 期
Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Presence of RGV (Residual Gastric Volume) in Stomach
研究概览
简要总结
To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).
Primary Outcomes:
- Residual gastric volume that precludes adequate endoscopic examination
- Residual gastric volume that necessitates premature termination of the endoscopy procedure
- Need for endotracheal intubation due to stomach contents.
- Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Secondary Outcomes:
- Presence of any solid food
- Presence of moderate liquid content
- Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).
- Differences in primary and secondary outcomes between different medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients using incretin-based therapies at a stable dose for more than 1 month.
- •Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.
排除标准
- •Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
- •Known history of achalasia
- •Surgical or genetically altered foregut anatomy
- •Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
- •Patients who did not follow the standard NPO (nil per oral) instructions.
研究组 & 干预措施
Continue medication as normal prior to endoscopic procedure
Active Comparator
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
干预措施: GLP-1 medication (Drug)
结局指标
主要结局
Presence of RGV (Residual Gastric Volume) in Stomach
时间窗: Procedure
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Tracking the Use of Intubation Due to RGV
时间窗: Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)
时间窗: Procedure
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
次要结局
未报告次要终点
研究者
Shah,Tilak
Principal Investigator
The Cleveland Clinic
研究点 (1)
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