Randomized Controlled Trial Comparing Diagnostic Yield for Small Bowel Endoscopy Between Novel Motorized Spiral and Single Balloon Enteroscopy in Suspected Crohn's Disease (the MOTOR-CD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Comparison of technical success with NMSE and SBE per patient [%]
研究概览
简要总结
Both single-balloon enteroscopy (SBE) and novel motorized spiral enteroscopy (NMSE) are effective techniques for small bowel endoscopy in suspected Crohn's disease (CD). Small bowel endoscopy is indicated for confirming diagnosis when CD is suspected based on clinical features along with cross-sectional small bowel imaging (computed tomography enterography/enteroclysis: CTE or magnetic resonance enterography/enteroclysis: MRE) or capsule endoscopy (CE). It not only helps in diagnosing CD, but it also helps in excluding CD, diagnosing alternate conditions and taking a surgical decision if a tight stricture is found. The pilot study done by the investigators in 177 suspected CD patients (37.2% female, 7-75 years) undergoing total 201 device assisted enteroscopy (DAE) showed that NMSE scores over SBE with regards to small bowel evaluation with complete small bowel coverage and shorter procedure time. The investigators aim to validate this findings by comparing technical performance and diagnostic yield between NMSE (Olympus Medical, Tokyo, Japan) and SBE (Olympus Medical Systems Corporation, Tokyo, Japan) for small bowel evaluation. Additionally the investigators plan to compare depth of insertion, total enteroscopy rates, procedure time, adverse event rates between the two modalities.
To date, no study has compared both modalities in suspected Crohn's disease (CD) requiring small bowel evaluation in a randomized manner. Hence the investigators intend to perform a randomized controlled study based on these preliminary finding with appropriate matching and parallel study design in larger numbers.
详细描述
Study design
Study population Consecutive patients with suspected Crohn's disease requiring small bowel endoscopy based on abnormal imaging or capsule endoscopy shall be recruited.
Study settings:
The proposed study would be conducted in a high volume tertiary GI centre (Asian Institute of Gastroenterology) performing nearly more than 500 SBE/NMSE procedures per year with an well established inflammatory bowel disease (IBD) registry with more than 7000 IBD patients under follow up.
The study is approved by the institutional review boards and ethics committee. Written informed consent would be taken from each participants and the study would conform to the 1975 Declaration of Helsinki ethical guidelines.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected of known IBD requiring small bowel endoscopy
- •Ability to give a signed informed consent.
- •Age ≥18 years -65 years -
排除标准
- •Patient not fit for general anaesthesia
- •Pediatric Patients (<18 years)
- •Pregnant or lactating mother
- •Post operative cases
- •Not willing to participate
结局指标
主要结局
Comparison of technical success with NMSE and SBE per patient [%]
时间窗: 2 years
Percentage of participants in which anatomical region of interest is reached
次要结局
- Comparison of procedure time with NMSE and SBE[minutes](2 years)
- Comparison of diagnostic yield with NMSE and SBE per procedure [%](2 years)
- Comparison of total enteroscopy rates with NMSE and SBE [percentage](2 years)
- Comparison of depth of maximal insertion with NMSE and SBE [centimetres](2 years)
- Comparison of adverse events with NMSE and SBE [percentage](2 years)
