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

Condition(s) studied

Investigational drug(s) / intervention(s)

Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment: 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.

Study 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

Primary outcome measure(s)

• Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-Colonoscopy — Day 1 (same day as colonoscopy)
  Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of mid-end ultrasound (Siemens ACUSON S2000) and high-end ultrasound (Samsung RS85) in detecting inflammation in the terminal ileum and colon, as compared to findings on ileo-colonoscopy (reference standard). Each patient will undergo both ultrasound examinations followed by ileo-colonoscopy. Sonographic features assessed include bowel wall thickness, mural stratification, and vascularity. Colonoscopy will be scored using validated endoscopic indices such as the Simple Endoscopic Score for Crohn's Disease and the Ulcerative Colitis Endoscopic Index of Severity.

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India