NCT07794410Recruiting
A Study Comparing Transperineal Ultrasound, Magnetic Resonance Imaging, Endoscopic Ultrasound, and Examination Under Anesthesia to Detect and Classify Perianal Fistulas in Patients With Crohn's Disease or Fistulas of Unknown Cause
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)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Aug 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 15 Apr 2027
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Crohn's disease
- NCT number
- NCT07794410
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 25 Jul 2025 to the primary completion date, 15 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI (e.g., presence of metal implants or claustrophobia)
- Prior surgery or seton placement at the index fistula site
Other illness
- Known or suspected anorectal malignancy
- Anesthesia required for EUA (e.g., significant cardiopulmonary disease)
Other
- Pregnancy or breastfeeding
- Contraindications to any of the imaging procedures:
- EUS (e.g., severe anal stenosis or intolerance to procedure)
- Incomplete or failed imaging in any one of the modalities
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.