Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Diagnostic value of the wireless capsule endoscopy
研究概览
简要总结
The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary complications.
In the paediatric population presenting with the PHT, one of every two children develops varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But the role of the VCE for examination of the other parts of digestive tract still needs to be evaluated.
For the esophagus, the VCE could allow the diagnosis without the need of general sedation. Recent studies have shown a good sensitivity and tolerance of this technique for the initial diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension, but it has not yet been validated for this indication.
The investigators hypothesize that the VCE could be used in children with similar results in term of efficacy, as for adults.
This prospective simple blind multicentre study (blind for the lecture of the capsule endoscopy record), will investigate the diagnostic value of the VCE compared to the conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and the control of esophageal varices in children.
If it is provided that the VCE is as efficient as it is for the adults, it could become a very interesting alternative to the conventional EGD because less expensive and less invasive. Moreover, this technique would be very useful as a means of early detection on the EV and/or their control.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 7 and 18 years old
- •presenting a portal hypertension and/or cirrhosis
- •patients who are referred for a conventional EGD under general sedation
- •patients who are not participating in other clinical studies
- •written informed consent obtained from the patient and his/her legal guardians.
排除标准
- •patients presenting a contra indication for upper endoscopy or for the ingestion of the video capsule, especially those with clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophile esophagitys)
- •patients presenting with dysphagia or gastrointestinal tract strictures (patients with Crohn's disease, small bowel carcinoma, stenosis due to the chronic use of a NSAI medication, acute necrotizing enterocolitis or prior abdominal surgery of the gastrointestinal tract); swallowing disorders with or without impaired consciousness;
- •patients under calcium channel blocking agents medication;
- •patient presenting with diverticulosis (Marphan's or Ehlers Danlos's syndrome)
- •patients with cardiac pacemaker or other implanted electro medical device
- •patients scheduled for a magnetic resonance imaging (MRI) examination within 7 days after ingestion of the capsule (and until the capsule is evacuated)
- •any other life-threatening conditions.
研究组 & 干预措施
video capsule endoscopy
干预措施: Wireless esophageal capsule endoscopy ( PillCam Eso2) (Device)
结局指标
主要结局
Diagnostic value of the wireless capsule endoscopy
时间窗: 1 week
The diagnostic value of the wireless capsule endoscopy as measured by the sensitivity of the wireless capsule endoscopy for the detection and the control of esophageal varices in children compared to the EGD sensitivity.
次要结局
- Feasibility and safety of the wireless capsule endoscopy(4 weeks)
- Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy(1 week)
- Applicability of the wireless capsule endoscopy(1 week)
- Acceptance of the wireless capsule endoscopy(1 week)