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

NCT ID: NCT06938295

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-14
• Study Completion Date: 2025-10-30

Brief 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.

Detailed Description

The HUMID Study (High-end versus Mid-end Ultrasound in Inflammatory Bowel Disease Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study designed to compare the performance of two intestinal ultrasound systems-a high-end system (Samsung RS85) and a mid-end system (Siemens ACUSON S2000)-in detecting ileocolonic inflammation in patients with inflammatory bowel disease. The study uses ileo-colonoscopy as the diagnostic reference standard and also evaluates the impact of ultrasound findings on clinical management and potential cost savings in resource-limited settings.

Eligible patients with known inflammatory bowel disease involving the colon and/or terminal ileum will undergo two intestinal ultrasound examinations followed by ileo-colonoscopy. To minimize operator bias, the mid-end ultrasound examination will be performed and interpreted by an experienced gastrointestinal sonologist using the Siemens ACUSON S2000 system. The high-end ultrasound examination will be conducted independently by an inflammatory bowel disease specialist using the Samsung RS85 system. Both sonographers will be blinded to each other's findings and to colonoscopy results. The examinations will be conducted in close succession on the same day, using standardized scanning protocols and probe frequencies suitable for bowel wall assessment.

Ultrasound assessments will include bowel wall thickness, mural stratification, vascularity, and disease extent. All findings will be recorded on pre-specified case report forms. Ileo-colonoscopy will be performed within 24 hours of the ultrasound exams by a separate blinded endoscopist. Endoscopic activity scores will be used as the reference standard for determining diagnostic accuracy.

The primary objective is to compare the diagnostic accuracy-measured by sensitivity, specificity, positive predictive value, and negative predictive value-of mid-end versus high-end ultrasound systems in detecting ileocolonic disease activity. The study aims to determine whether mid-end machines, which are more affordable and accessible, can offer comparable diagnostic performance to high-end systems.

Secondary objectives include assessing whether ultrasound findings lead to changes in clinical management. To ensure objectivity, an independent panel of three experienced inflammatory bowel disease physicians-blinded to the identity of the ultrasound machine-will review each case and determine whether ultrasound findings would have justified changes such as treatment escalation or de-escalation, surgical referral, or additional diagnostic evaluation. Panel decisions will be based on standardized clinical scenarios and will be adjudicated by consensus.

The study also includes a health-economic component, analyzing how the integration of mid-end ultrasound into clinical workflows may reduce reliance on invasive and high-cost diagnostics like colonoscopy or cross-sectional imaging. Real-world cost estimates will be used to model the economic impact.

By providing comparative data on diagnostic accuracy, management impact, and economic value, the HUMID Study seeks to inform clinical practice guidelines and promote the use of scalable ultrasound solutions in inflammatory bowel disease, particularly in resource-constrained healthcare settings.

Conditions

Inflammatory Bowel Disease (IBD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adult patients with inflammatory bowel disease

Participants will undergo intestinal ultrasound (IUS) assessments using both a high-end (Samsung RS85) and a mid-end (Siemens ACUSON S2000) ultrasound machine to evaluate ileocolonic inflammation in inflammatory bowel disease (IBD). Each device is used within the same session, focusing on bowel wall thickness, vascularity, and structural changes. The high-end ultrasound provides advanced imaging capabilities, while the mid-end device offers standard IUS functionalities. Tandem ileo-colonoscopy is performed as the reference standard to validate findings.

Primary Outcome: Diagnostic accuracy (sensitivity, specificity) of high-end vs. mid-end ultrasound.

Secondary Outcome: Impact of ultrasound findings on clinical management decisions, evaluating cost-effective options for routine IBD monitoring.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Partha Pal, MD, DNB, MRCP (UK), FASGE

Role: CONTACT

partha0123456789@gmail.com

+91-8945906823

Facility Contacts

Duvvuru Nageshwar Reddy, MD, DM, MASGE, FACG, AGAF

Role: primary

aigindia@yahoo.co.in

+91-40-23378888

Other Identifiers

AIG/IEC-BH&R 61/09.2024-01

Identifier Type: -

Identifier Source: org_study_id