Perianal fistula imaging comparison using TPUS, MRI, EUS, and EUA
Official title: 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)
Run by Asian Institute of Gastroenterology, India · NCT07794410 · Data updated 2026-11-12
This study tests how well four imaging methods—transperineal ultrasound, MRI, endoscopic ultrasound, and examination under anesthesia—detect and describe perianal fistulas in adults with Crohn's disease or unknown cause.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telanagana) |
| Status | Recruiting |
| Started | July 25, 2025 |
| Main results expected | April 15, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07794410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with suspected or confirmed perianal fistulas due to Crohn's disease or cryptogenic causes, able to complete all four imaging tests within 10 days.
✕Probably not a fit
Patients who cannot undergo one or more imaging procedures or whose fistula anatomy is not clarified by imaging may not benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares four imaging tests to detect and classify perianal fistulas in adults. Participants will undergo TPUS, MRI, EUS, and EUA within a 10-day period to assess accuracy in identifying fistula tracts, internal openings, and abscesses. Results will inform how these tests influence treatment decisions. The study acknowledges that perianal fistulas are common in Crohn's disease and can be challenging to diagnose and treat. The trial is conducted at a single center in Hyderabad, India, led by the Asian Institute of Gastroenterology.
Why it matters
Potential benefit: If successful, the findings could improve non-invasive imaging choices and guide more precise treatment planning for perianal fistulas.
How similar studies have gone: Previous work supports MRI as a strong reference standard for fistula anatomy, but direct comparisons with TPUS and EUS in this context are less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Known or suspected anorectal malignancy * Pregnancy or breastfeeding * Contraindications to any of the imaging procedures: * MRI (e.g., presence of metal implants or claustrophobia) * EUS (e.g., severe anal stenosis or intolerance to procedure) * Anesthesia required for EUA (e.g., significant cardiopulmonary disease) * Prior surgery or seton placement at the index fistula site * Incomplete or failed imaging in any one of the modalities * Inability to provide informed consent
Where it's running
-
Asian Institute of Gastroenterology
Hyderabad, Telanagana, India Recruiting
Study contacts
- Study coordinator: Partha Pal, MD, DNB, MRCP (UK), FASGE
- Email: partha0123456789@gmail.com
- Phone: +918945906823
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.