RecruitingNot ApplicableNCT06938295

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

Sponsor

Asian Institute of Gastroenterology, India

Enrollment

500 participants

Start Date

Sep 14, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Disease (IBD)

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Patients aged 18-75 years.
Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
Clinically stable at the time of assessment.
Willing and able to undergo both intestinal ultrasound (IUS) assessments (mid-end and high-end) and the reference standard ileo-colonoscopy.
Provides informed consent to participate in the study.

Exclusion Criteria4

Pregnant or breastfeeding individuals.
Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
Individuals unable to provide informed consent.
Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour

Interventions

DIAGNOSTIC_TESTComparative 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.