The Use Of PillCam Esophagus In Triaging Patients Presented With Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- The number of patients requiring hospital admission
研究概览
简要总结
Background
- Patients presented to hospital with coffee ground vomiting and black stool may not be actually having upper gastrointestinal bleeding (UGIB)
- Hospital admission can be avoided if serious UGIB can be excluded
- To date, the only useful tool to triage patient for hospital admission in UGIB is by using clinical score such as Rockall score or Blatchford score
- These scores are cumbersome and only exclude the most benign cases, but they are not useful in differentiating those who needs intervention
- In our pilot study, investigators found that capsule endoscopy can be used to identify patients with fresh blood and real coffee ground substance in the stomach and it is superior to nasogastric tube
- Most of UGI lesions leading to bleeding can be diagnosed by capsule endoscopy
Objectives The current study is designed
- to validate capsule endoscopy is an effective method in identifying patients with UGIB
- to study whether the capsule endoscopy can reduce requirement of hospital admission in patients with suspected UGIB
- to study if capsule endoscopy can help to identify patients with UGIB that may require urgent (within 24 hours) endoscopy and intervention
- to study the cost-effectiveness of capsule endoscopy being used as a triaging tool in the management of UGIB
- to compare the effectiveness of capsule endoscopy against Blatchford score in identifying patients with UGIB that may require endoscopic intervention.
详细描述
Hypothesis PillCam Esophagus is effective in identifying genuine UGIB and hence able to reduce hospital admission due to unsubstantiated UGIB cases
Methodology
-
Patients presented to the Accident & Emergency Department (A&ED) of the Prince of Wales Hospital Hong Kong with symptoms suggestive of UGIB will be recruited into this study
-
Patients will receive the following tests
-
Complete blood count
-
Coagulation profile
-
Renal and liver function tests
-
Hourly BP, Pulse up to 6 hours
-
Glasgow Blatchford score calculated on admission
-
Randomization
-
Capsule Group: Capsule Endoscopy (CE) by using PillCam Esophagus (PillCam ESO) OR
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Standard group: Hospitalization and Standard of Care
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The video in capsule endoscopy will be read by trained personnel who have undergone at least one hour lecture about realtime reviewing.
-
Legally a patient has to be signed off by a clinician within 6 hours. The finding of fresh blood or coffee ground will be documented. Upper GI pathology that may lead to bleeding will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena
排除标准
- •UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy,
- •UGIB with fresh hematemesis requiring urgent endoscopy
- •dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation,
- •prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery.
- •presence of an electromedical device (pacemaker or internal cardiac defibrillator),
- •altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent.
- •Allergy to Maxolon
- •Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes
- •Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer
结局指标
主要结局
The number of patients requiring hospital admission
时间窗: 24 hours
Patients with evidence of significant bleeding will be admitted to ward and receive early endoscopy (EGD)
次要结局
- Clinical rebleeding(30 days)
- Mortality(30 days)
- Comparing the effectiveness of CE against Glasgow Blatchford score in identifying patients with UGIB that may require endoscopic intervention(30 days)
- Cost of management in different strategies(One year)
研究者
Joseph JY SUNG
Professor
Chinese University of Hong Kong