Methodology and Clinical Value of Retrograde Imaging Technique in Intestinal Obstructive Diseases Mediated by Colonic Transendoscopic Enteral Tubing
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
- The diagnostic self-confidence score
研究概览
简要总结
The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE（Multi-slices spiral computed tomography enterography） and MRE（ Magnetic resonance enterography）require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD（Crohn's Disease） patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation；
- •Abdominal X-ray or plain CT showed signs of intestinal obstruction;
- •Participants suspected with intestinal stricture according to the recent lower GI endoscopy；
- •Voluntarily sign written informed consent.
排除标准
- •Signs of peritonitis, perforation or massive hemorrhage of digestive tract;
- •Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy;
- •Allergic to laxatives or iodine contrast agents;
- •Pregnant women;
- •Confirmed or suspected claustrophobia;
- •Inability to understand or provide informed consent
结局指标
主要结局
The diagnostic self-confidence score
时间窗: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.
Image parameters of the lesion( i e. Location，Nature, Severity, Appearance, Fistula) will be recorded by the reader. The diagnostic self-confidence for each image parameter will be determined using a continuous five-grade scoring system from 1 to 5(1 = worst, 2=worsen, 3=normal, 4= better,5 = best). For example: The doctor's diagnostic self-confidence for Location is worsen ,then the diagnostic self-confidence score will be recorded as 2。
Evaluation of comprehensive diagnostic efficiency
时间窗: immediately after CT/X-ray fluoroscopy detection，no more than 24hours.
comprehensive diagnostic efficiency=(Location+Nature+Appearance+Fistula+Proximal lesion filled by contrast fluid）. Each positive parameter will be recorded as mark 1, negative mark 0. Each participant will get up to 5 score. For example: for some one participant ,if the doctor could determine the location and nature of the lesion, however,appearance, fistula and proximal lesion filled by contrast fluid could not be determined, then ,the score of comprehensive diagnostic efficiency equals 2.
次要结局
- Tolerance(during the process, and no more than 24hours after CT/X-ray fluoroscopy detection)
- Adverse reaction(during the process, and no more than 24hours after CT/X-ray fluoroscopy detection)
研究者
Faming Zhang
Associate professor, Gastroenterology
The Second Hospital of Nanjing Medical University