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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

Sponsor: Asian Institute of Gastroenterology, India • ClinicalTrials.gov ID: NCT07794410

Registry updated: 2026-08-31
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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: 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.

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.

Eligibility 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

Conditions

Crohn Disease (CD) Cryptoglandular Perianal Fistula

Locations

  • Asian Institute of Gastroenterology — Hyderabad, Telanagana, India
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record