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
Not applicable · Testing Transperineal Ultrasound (TPUS), Magnetic Resonance Imaging (MRI) and Endoscopic… · 1 site · Asian Institute of Gastroenterology, India
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Transperineal Ultrasound (TPUS) (a diagnostic test), Magnetic Resonance Imaging (MRI) (a diagnostic test), Endoscopic Ultrasound (EUS) (a diagnostic test) and Examination Under Anesthesia (EUA) (a diagnostic test) as a way to diagnose or measure disease. Condition(s) listed: Crohn Disease (CD) and Cryptoglandular Perianal Fistula.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2025-07-25.
- Main results expected around 2027-04-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in India.
Main thing being measured
- Per-lesion sensitivity of transperineal ultrasound (TPUS) and magnetic resonance imaging (MRI) for detecting perianal fistulas (Within 10 days of enrollment (all four imaging modalities completed within this window))
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD); Cryptoglandular Perianal Fistula |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Enrollment | 50 (estimated) |
| Start date | 2025-07-25 |
| Primary completion (est.) | 2027-04-15 |
| First posted | 2026-08-31 |
| Last updated | 2026-08-31 |
| 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) |
| ClinicalTrials.gov ID | NCT07794410 |
Interventions
- Transperineal Ultrasound (TPUS) (Diagnostic Test)
Participants will undergo TPUS using a high-frequency linear and microconvex probe to evaluate fistula tracts, internal openings, and abscesses. - Magnetic Resonance Imaging (MRI) (Diagnostic Test)
MRI of the pelvis will be performed using standardized T2-weighted, STIR, and post-contrast sequences for anatomical characterization of fistulas. - Endoscopic Ultrasound (EUS) (Diagnostic Test)
EUS of the anorectal canal will be performed using a linear echoendoscope to visualize internal openings, fistula tracts, and perirectal collections. EUS serves as the reference standard. - Examination Under Anesthesia (EUA) (Diagnostic Test)
Participants will undergo EUA by a colorectal surgeon to probe fistula tracts and identify internal openings. EUA serves as the gold standard comparator.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad, Telanagana | India | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.