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Can a simple ultrasound replace MRI for fistula diagnosis?

NCT ID NCT07794410

Diagnosis Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study asks how well different imaging tests detect and describe perianal fistulas, painful tunnels near the anus that can affect people with Crohn's disease or arise without a known cause. Researchers will compare transperineal ultrasound (TPUS) and MRI against two other methods: endoscopic ultrasound (EUS) and examination under anesthesia (EUA). Adults aged 18 to 75 with suspected or confirmed fistulas will undergo all four tests within 10 days. The goal is to see if TPUS can match MRI's accuracy, which could make diagnosis faster, safer, and more affordable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diagnostic imaging tests: transperineal ultrasound (TPUS), magnetic resonance imaging (MRI), endoscopic ultrasound (EUS), and examination under anesthesia (EUA)
What this could lead to
If TPUS proves as accurate as MRI, it could become a faster, cheaper first-line tool for diagnosing perianal fistulas, especially where MRI or surgery is hard to access.
What could go wrong
This is a small study (50 participants) and compares diagnostic accuracy, not treatment outcomes. TPUS may not match MRI's detail in all cases, and results may not apply to all fistula types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease Fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease (CD) Cryptoglandular perianal fistula

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asian Institute of Gastroenterology

    RECRUITING

    Hyderabad, Telanagana, 500082, India

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