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The MOTOR-CD Trial

Asian Institute of Gastroenterology, India · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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crohn-s-diseasena
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.
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