Comparing Diagnostic Accuracy of High-end Intestinal Ultrasound Versus Mid-end Ultrasound With Tandem Ileo-colonoscopy in Inflammatory Bowel Disease : a Paired, Validating Confirmatory Study
Comparing Diagnostic Accuracy of High-End Intestinal Ultrasound Versus Mid-End Ultrasound With Tandem Ileo-Colonoscopy in Inflammatory Bowel Disease (The HUMID Study): A Paired, Validating Confirmatory Study
Asian Institute of Gastroenterology, India
500 participants
Sep 14, 2024
INTERVENTIONAL
Conditions
Summary
The HUMID Study (High-end vs. Mid-end Ultrasound in IBD Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study evaluating the performance of mid-end versus high-end intestinal ultrasound (IUS) machines in assessing ileocolonic involvement in patients with inflammatory bowel disease (IBD). Conducted at the Asian Institute of Gastroenterology, this study compares the Siemens ACUSON S2000 (mid-end) with the Samsung RS85 (high-end) ultrasound machines, using ileo-colonoscopy as the reference standard. All enrolled patients will undergo clinical evaluation, IUS with both machines, and colonoscopy. The primary objective is to assess and compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the two ultrasound systems. Secondary objectives include evaluating the impact of IUS findings on clinical management. The study aims to provide evidence for cost-effective imaging strategies in resource-limited settings where access to advanced diagnostics is restricted.
Eligibility
Plain Language Summary
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Interventions
This study compares two intestinal ultrasound (IUS) devices-a high-end machine (Samsung RS85) and a mid-end machine (Siemens ACUSON S2000)-for assessing ileocolonic inflammation in IBD patients. The high-end device offers advanced imaging features, including high-resolution, speckle reduction, and extended field of view, allowing for detailed visualization of the bowel wall and vascularity. The mid-end device, while more basic, provides essential IUS functions for examining bowel wall thickness, structure, and inflammation markers. Both devices are used in a single clinical session, with results compared against tandem ileo-colonoscopy as the reference standard. This unique dual approach enables evaluation of the diagnostic performance of each device type. If comparable, the mid-end device may offer a cost-effective solution, increasing access to routine IUS in various healthcare settings, especially where high-end technology is limited.
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NCT06938295