Magnetically Controlled Capsule Endoscopy First vs. Standard Algorithm in Patients With Melena (FIRM Trial): a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The rate of bleeding lesions detection.
研究概览
简要总结
MCE first algorithm is not inferior to standard of care algorithm in terms of further bleeding in hemodynamically stable patients with acute overt and non-hematochezia GI bleeding.
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
- •Age ≥ 18 years
- •Presenting to the outpatient department or emergency department with melena (without hematemesis) within the previous 48 hours
- •Hemodynamically stable (blood pressure > 100/60 mmHg and heart rate < 100 bpm) at presentation
- •No endoscopy performed after the new onset of melena
排除标准
- •Presenting with hematochezia and/or hematemesis within the previous 48 hours of presentation
- •Hemodynamically stable after initial volume resuscitation
- •Drop of hemoglobin level ≥ 2 g/dL/day, and/or need of transfusion ≥ 2 units of packed red blood cells per day
- •Contraindications of CE (e.g. dysphagia, Zenker's diverticulum, esophageal stricture, known or suspected gastric or small bowel obstruction or perforation, gastroparesis, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation, etc.)
- •Presence of internal cardiac defibrillator (ICD), pacemaker and/or other implanted electronic devices (cochlea, drug infusion pump, nerve stimulator, etc.) or magnetic metal foreign bodies; possibility of requiring an MRI examination prior to capsule excretion
- •Patients who cannot undergo surgery in the event of capsule retention
- •Pregnant and/or lactating women
- •Patients with altered mental status (such as hepatic encephalopathy)
- •Patients moribund from terminal malignant diseases or other end-stage illnesses with a limited life expectancy
- •Unable to consent
研究组 & 干预措施
MCE first group
Patients randomized to the "MCE first group" will have a MCE deployed as the first detection method.
干预措施: MCE first (Diagnostic Test)
standard of care group
For patients randomized to the Standard Care Group, gastroenterologists choose which procedures to perform and when to perform them based on their interpretation of the patient's presentation.
结局指标
主要结局
The rate of bleeding lesions detection.
时间窗: 1 month
Detection rate of bleeding lesions is defined as proportion of patients in whom a potential bleeding lesion is identified. Visualization of gross blood (fresh/coffee grounds) without any lesion will not be considered as a positive diagnosis. The panel will provide a diagnosis based upon the lesion presenting the highest potential for bleeding if there are many lesions detected.
次要结局
- The time of the bleeding lesions detected from admission(1 month)
- The number of procedures patients underwent for detection of the bleeding lesions(1 month)
- Time to therapeutic intervention from presentation(1 month)
- The length of hospital stay(1 month)
- The all-cause mortality within 30 days of discharge(1 month)
- Transfusion rate(1 month)
- The number of colonoscopy needed(1 month)
- Rate of therapeutic intervention required of all patients(1 month)
- The cumulative direct cost of hospitalization(1 month)
- The rate of recurrent bleeding within 30 days of discharge(1 month)
研究者
Zhuan Liao
M.D., Associate Professor, Associate Chief Physician
Changhai Hospital