Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Lesions detected
研究概览
简要总结
Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.
详细描述
The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled.
Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study.
In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis).
Patients at high risk of celiac disease complications are defined as
- subjects older than 50 years at the time of celiac disease diagnosis
- subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet
- subjects reporting poor compliance to the gluten-free diet
- subjects with alarm signs at diagnosis or during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The videos will be reviewed by three experts operators blinded about the sequence of capsule examination administration
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
- •Adult patients with celiac disease at high risk of complication (see above for a detailed description)
排除标准
- •presence of Pacemaker or Defibrillator
- •suspected small bowel obstruction
- •impaired swallowing
- •pregnancy
- •presence of contraindications to a capsule endoscopy examination
研究组 & 干预措施
Lateral-viewing capsule
Examination of the small bowel by means of the lateral-viewing CapsoCam device
干预措施: Lateral-viewing CapsoCam device (Device)
Axial-viewing capsule
Examination of the small bowel by means of the axial-viewing capsule
干预措施: Axial-viewing capsule (Device)
结局指标
主要结局
Lesions detected
时间窗: up to 24 hours, the time of progression of the capsule through the small bowel
Mean number of lesions detected by the two different types of devices, expressed as diagnostic yield and total number of lesions
次要结局
- Extension of the lesions(up to 24 hours, the time of progression of the capsule through the small bowel)
研究者
Luca Elli
MD, PhD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico