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
Key facts
- Where
- Hyderabad, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07794410, who can take part
Where in India
- Asian Institute Of GastroenterologyHyderabad, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asian Institute of Gastroenterology, India
- Trial code
- NCT07794410
- Record updated
- 31 August 2026
- Original description
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:Read full original descriptionShow less
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)
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.
Inclusion: 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: MRI (e.g., presence of metal implants or claustrophobia); Prior surgery or seton placement at the index fistula site; Known or suspected anorectal malignancy; Anesthesia required for EUA (e.g., significant cardiopulmonary disease); 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.