Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography (CTE)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Performance of two neutral oral contrast agents in CT enterography.
研究概览
简要总结
CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. There are several shortcomings of commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 18 to 75
- •patients undergoing CT enterography
排除标准
- •patients with a history of colorectal surgery
- •patients with severe colonic stricture or obstructing tumor
- •patients with significant gastroparesis or gastric outlet obstruction
- •patients with known or suspected bowel obstruction or perforation
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •patients with severe inflammatory bowel disease or megacolon
- •patients with documented allergy to intravascular contrast agent
- •patients with dehydration
- •patients with pregnancy or lactation
- •patients hemodynamically unstable
- •patients with dysphagia
- •patients with severe constipation.
- •patients unable to give informed consent.
研究组 & 干预措施
mannitol
Participants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination.
干预措施: mannitol (Drug)
polyethylene glycol
Participants are given a minimum of 1500 mL of a preparation of polyethylene glycol as oral contrast agent over an hour prior to the examination.
干预措施: polyethylene glycol (Drug)
结局指标
主要结局
Performance of two neutral oral contrast agents in CT enterography.
时间窗: 12 months
The assessment system includes six parts. 1. Whether the contrast reached the caecum is evaluate and recorded as 'yes' or 'no'. 2. The overall presence of inhomogeneous contrast is evaluated and recorded as 'yes' or 'no'. 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended ≥2 cm are evaluated and recorded as '0-25%', '26-50%', '51-75%' and '76-100%'. 5. The wall visibility and visualization of the small-bowel mucosal are scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome. 6. Overall quality is assessed subjectively by the radiologist and scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome.
次要结局
- Side effects of the two oral contrast agents.(12 months)
- Blood pressure of patients.(12 months)
- The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography.(12 months)
- Temperature of patients.(12 months)
- Dizziness and debilitation of patients.(12 months)
研究者
Yanqing Li
Professor
Shandong University