Urgent vs. Early Endoscopy in High Risk Patients With UGIB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.
Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.
详细描述
The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
- •In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
- •Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized.
排除标准
- •continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
- •< 18 years of age
- •Unable to provide written informed consent
- •Pregnant or lactating women
- •Moribund patients from terminal illnesses. (active treatment not considered)
研究组 & 干预措施
Urgent endoscopy
Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
干预措施: Urgent endoscopy (Other)
Early endoscopy
Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
干预措施: Early endoscopy (Other)
结局指标
主要结局
Mortality
时间窗: 30 days
Death from all causes 30 days from randomization
次要结局
- Need for endoscopic therapy at index endoscopy(At the time of index endoscopy)
- Need for transfusion(Within 30days of randomization)
- Recurrent bleeding as defined(Within 30days of randomization)
- Duration of hospital stay of index bleeding(Within 30 days of randomization)
- ICU stay(Within 30days of randomization)
- Need for further endoscopic treatment(Within 30days of randomization)
- Emergency surgery or interventional radiology to achieve hemostasis(Within 30days of randomization)
- Rates of recurrent bleeding(Within 30 days of randomization)
- Rate of adverse events(Within 30 days of randomization)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong