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A Quadrimodal Comparison of Transperineal Ultrasound and Magnetic Resonance Imaging-based Sonographic Investigation With Integrated Testing Using Endoscopic Ultrasound and Examination Under Anesthesia for the Assessment of Perianal Fistulas in Patients With Crohn's Disease and Fistulas of Cryptogenic Origin (TRANSIT-CD Study)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to learn how well different imaging tests detect and describe perianal fistulas in adults with Crohn's disease or fistulas with no known cause (cryptogenic). Perianal fistulas are painful tunnels that form near the anus and can lead to discharge, swelling, or infection. The main questions this study aims to answer are: How accurate is transperineal ultrasound (TPUS) compared to magnetic resonance imaging (MRI) in finding fistulas? How well do these tests identify key features like internal openings and abscesses? Do the test results help doctors make better treatment decisions? Researchers will compare TPUS and MRI to two other imaging methods: Endoscopic ultrasound (EUS), which uses a small camera and ultrasound inside the rectum Examination under anesthesia (EUA), in which a surgeon checks the area while the participant is asleep All participants will: Be adults between the ages of 18 and 75 Have a suspected or confirmed perianal fistula Be able to complete all four tests-TPUS, MRI, EUS, and EUA-within 10 days Participants will not receive any experimental treatments. The tests are part of routine care and will be done using advanced equipment by expert doctors. Each test result will be used to compare how accurate and useful the test is in real-life diagnosis and treatment planning. This study may help make fistula diagnosis faster, safer, and more affordable-especially in settings where access to MRI or surgery is limited. It may also support the use of TPUS as a first step in evaluating perianal fistulas in people with Crohn's disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adults between 18 and 75 years of age

• Clinical suspicion or diagnosis of perianal fistula

• Fistula etiology can be Crohn's disease or cryptogenic/tubercular (non-Crohn's)

• Ability to undergo all four imaging procedures (TPUS, MRI, EUS, and EUA) within a 10-day period

• Willing and able to provide written informed consent

Locations
Other Locations
India
Asian Institute of Gastroenterology
RECRUITING
Hyderabad
Contact Information
Primary
Partha Pal, MD, DNB, MRCP (UK), FASGE
partha0123456789@gmail.com
+918945906823
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 50
Treatments
Experimental: Single Group: Quadrimodal Imaging Assessment
All participants in this arm will undergo four diagnostic imaging procedures-transperineal ultrasound (TPUS), magnetic resonance imaging (MRI), endoscopic ultrasound (EUS), and examination under anesthesia (EUA)-in a predefined sequence. Each imaging modality will be used to evaluate the presence, type, and extent of perianal fistulas. This single-arm design allows within-subject comparison of diagnostic accuracy and clinical impact across modalities.
Related Therapeutic Areas
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov