Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Percentage of patients with 'adequate visualization'
研究概览
简要总结
This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
详细描述
- This is double-blinded, multicenter RCT including six hospitals in Thailand.
- The participated endoscopists had work experience for endoscopy more than three years.
- All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system.
- The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal.
- All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
- This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (aged ≥ 18years)
- •Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.
排除标准
- •known allergy to metoclopramide
- •prior gastric or duodenal surgery
- •known case of esophageal, gastric or duodenal cancer;
- •advanced HIV infection (defined as WHO criteria13-15: CD4 <200 cell/mm3 or WHO clinical stage 3 or 4)
- •pregnancy
- •gastric lavage was performed with solution > 50 ml.
研究组 & 干预措施
Metoclopramide group
Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD
干预措施: Metoclopramide Sulfone (Drug)
Placebo group
NSS 10 ml IV 30-60 min before EGD
干预措施: Normal Saline 10 mL Injection (Drug)
结局指标
主要结局
Percentage of patients with 'adequate visualization'
时间窗: Through study completion, estimate 2 years
'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score \>=6 considered as adequate visualization
次要结局
- Length of hospital stays(1day - 30days)
- Duration of esophagogastroduodenoscopy(10minutes to 2 hours)
- Immediate hemostasis(Through study completion, estimate 2 years)
- The mean difference in EVS(Through study completion, estimate 2 years)
- The need for a second look EGD within 72 hours after initial endoscopy(Up to 72 hours)
- 30-day rebleeding rate(Up to 30 days)
- Number of unit of red blood cell transfusion during first 24 hours(Up to 24 hours)
研究者
Rapat Pittayanon
Associate Professor
King Chulalongkorn Memorial Hospital