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

NCT06938295 | Recruiting

• 1 other identifier: AIG/IEC-BH&R 61/09.2024-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Ultrasound; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-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.

  Day 1 (same day as colonoscopy)

Secondary Outcomes (1)

• Number of Participants With Change in Clinical Management Based on Ultrasound Findings as Determined by Independent Physician Panel

  Within 24 hours of ultrasound examination

Study Arms (1)

Adult patients with inflammatory bowel disease

ACTIVE COMPARATOR

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.

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

Interventions

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

Adult patients with inflammatory bowel disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

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

CONTACT

+91-8945906823; partha0123456789@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: April 22, 2025
• Study Start: September 14, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)