Crohn DiseaseTPUS-MRINCT05721794
Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study
An observational study of Crohn Disease and Perianal Fistula, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Perianal Fistula
- What is being tested?
- A multicentric prospective observational longitudinal cohort study.
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2022to 6 Jun 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 adult patients with confirmed diagnosis of Crohn's disease and suspicion of perianal fistulae will be enrolled in the study. Number and length of fistulae will be evaluated through MRI and TPUS. In addition, the response to treatment, defined as rate of fistula closure will also be evaluated with both techniques
Who may be able to join
- Patients >18 years
- Confirmed diagnosis of Crohn's disease.
- Clinical suspicion of perianal fistulae (e.g., perianal pain or swelling, drainage of pus, stool or stool from cutaneous fistula opening, and signs and symptoms of sepsis)
- Able to understand and sign an informed consent form
Who cannot join
- Controindications to MRI
- Severe comorbidities that limit the performance of MRI and TPUS
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mariangela Allocca
Milan, 20132
Mariangela Allocca, 0226432069, allocca.mariangela@hsr.it
About this study
Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent fibrosis, or penetrating lesions, such as fistulas, between two different intestinal tracts or between intestine and surrounding organs. Fistula occurrence can lead to formation of abdominal or pelvic abscesses. Such complications cause intestinal damage and usually require surgery, leading to disability, impairment of patients' quality of life, with significant impact on direct and indirect health-care costs
Read the detailed description
The investigators aim to conduct a multicentric pilot prospective observational study on the accuracy of TPUS and MRI in the investigation of perianal fistulae in CD patients. Fifty adult patients with confirmed diagnosis of Crohn's disease and perianal fistulae will be enrolled by five international centres between June 2022 and June 2023.
According to the observational nature of the study, all the visits and procedures described below will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. TPUS and MRI are normally performed by clinical practice. The choice of treatment for the cure of the fistula (e.g. medical and / or surgical treatment) will be made by the referring physicians according to the international ECCO guidelines. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.
Subjects will undergo both TPUS and pelvic MRI at baseline as for clinical practice. After radiological and ultrasound evaluation, subjects will be treated according to international ECCO guidelines. In particular, patients will undergo seton insertion and 2 weeks later they will start biologics at the discretion of the gastroenterologist in according with international guidelines . Surgical closure with the advancement flap (AF) or Ligation of the Intersphincteric Fistula Tract (LIFT) procedure will occur 8-12 weeks after seton placement, with seton removal during surgical closure. The choice of surgical technique will be at the discretion of the surgeon. Finally patients will undergo both TPUS and pelvic MRI after 12 months as for clinical practice.
TPUS findings will be compared with those of the standard MRI to assess perianal disease activity. For that purpose, the investigators will:
- Identify 50 CD patients with perianal fistulae. Those patients will undergo both standard pelvic MRI and TPUS.
- Treat all patients with perianal fistulae according to international guidelines (e.g., medical and/or surgical treatment).
- Monitor all patients included according to the scheduled follow-up to evaluate the value of TPUS findings in assessing perianal disease evolution.
Fistulae identified will be classified according to the MAGNIFI-CD Activity Index, a validated score ranging from 0 to 25. For both TPUS and MRI the positive value, indicating the presence of the fistula, is considered for a MAGNIFI-CD>6. It evaluates several items including the number of fistulas, length of fistulas, extension, presence of inflammatory mass, dominant features, and hyperintensity on post-contrast T1-weighted images. The investigators will calculate the MAGNIFI-CD also with the TPUS and they will evaluate if the results of the score obtained with the ultrasound are correlated to those obtained with the MRI.
- Conditions
- Crohn Disease, Perianal Fistula
- Being tested
- A multicentric prospective observational longitudinal cohort study.
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multicentric prospective observational longitudinal cohort study.Other
Observational study on the accuracy of TPUS and MRI in the investigation of perianal fistulae in CD patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of perianal fistulae through the MAGNIFI-CD index (by TPUS) and the standard MAGNIFI-CD index (by MRI)
To compare the accuracy of the TPUS versus pelvic MRI in assessing perianal fistulae in CD patients. Accuracy is defined as the ability to identify perianal fistulae
Measured: 1 year
Secondary outcomes (1)
Rate of fistula closure, determined by the clinician, at 12 months.
To compare the accuracy of the TPUS versus pelvic MRI in evaluating response to treatment in CD patients with fistulae
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start18 Jul 2022
- Primary completion6 Jun 2023 (estimated)
- Study completion6 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Allocca, IRCCS San Raffaele
- Investigators
- Mariangela Allocca, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721794
- Sponsor's protocol ID
- TPUS-MRI
- Acronym
- TPUS-MRI
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Accuracy of Transperineal Ultrasound (TPUS) Versus Magnetic Resonance Imaging (MRI) for the Assessment of Perianal Fistulae in Patients With Crohn's Disease (CD): a Prospective Observational Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05721794
- Acronym / sponsor ID
- TPUS-MRI / TPUS-MRI
- Conditions
- Crohn Disease, Perianal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 6 Jun 2023 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crohn's disease (CD) is a life-long chronic inflammatory bowel disease (IBD) that may affect any site of the gastrointestinal tract, most frequently the ileum and colon. It is characterized by transmural inflammation and it can lead to strictures, due to activation of reparation of inflamed tissues and consequent fibrosis, or penetrating lesions, such as fistulas, between two different intestinal tracts or between intestine and surrounding organs. Fistula occurrence can lead to formation of abdominal or pelvic abscesses. Such complications cause intestinal damage and usually require surgery, leading to disability, impairment of patients' quality of life, with significant impact on direct and indirect health-care costs
Detailed description
The investigators aim to conduct a multicentric pilot prospective observational study on the accuracy of TPUS and MRI in the investigation of perianal fistulae in CD patients. Fifty adult patients with confirmed diagnosis of Crohn's disease and perianal fistulae will be enrolled by five international centres between June 2022 and June 2023.
According to the observational nature of the study, all the visits and procedures described below will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. TPUS and MRI are normally performed by clinical practice. The choice of treatment for the cure of the fistula (e.g. medical and / or surgical treatment) will be made by the referring physicians according to the international ECCO guidelines. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.
Subjects will undergo both TPUS and pelvic MRI at baseline as for clinical practice. After radiological and ultrasound evaluation, subjects will be treated according to international ECCO guidelines. In particular, patients will undergo seton insertion and 2 weeks later they will start biologics at the discretion of the gastroenterologist in according with international guidelines . Surgical closure with the advancement flap (AF) or Ligation of the Intersphincteric Fistula Tract (LIFT) procedure will occur 8-12 weeks after seton placement, with seton removal during surgical closure. The choice of surgical technique will be at the discretion of the surgeon. Finally patients will undergo both TPUS and pelvic MRI after 12 months as for clinical practice.
TPUS findings will be compared with those of the standard MRI to assess perianal disease activity. For that purpose, the investigators will:
- Identify 50 CD patients with perianal fistulae. Those patients will undergo both standard pelvic MRI and TPUS.
- Treat all patients with perianal fistulae according to international guidelines (e.g., medical and/or surgical treatment).
- Monitor all patients included according to the scheduled follow-up to evaluate the value of TPUS findings in assessing perianal disease evolution.
Fistulae identified will be classified according to the MAGNIFI-CD Activity Index, a validated score ranging from 0 to 25. For both TPUS and MRI the positive value, indicating the presence of the fistula, is considered for a MAGNIFI-CD>6. It evaluates several items including the number of fistulas, length of fistulas, extension, presence of inflammatory mass, dominant features, and hyperintensity on post-contrast T1-weighted images. The investigators will calculate the MAGNIFI-CD also with the TPUS and they will evaluate if the results of the score obtained with the ultrasound are correlated to those obtained with the MRI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 adult patients with confirmed diagnosis of Crohn's disease and suspicion of perianal fistulae will be enrolled in the study. Number and length of fistulae will be evaluated through MRI and TPUS. In addition, the response to treatment, defined as rate of fistula closure will also be evaluated with both techniques
Key inclusion criteria (4 listed)
- Patients >18 years
- Confirmed diagnosis of Crohn's disease.
- Clinical suspicion of perianal fistulae (e.g., perianal pain or swelling, drainage of pus, stool or stool from cutaneous fistula opening, and signs and symptoms of sepsis)
- Able to understand and sign an informed consent form
Key exclusion criteria (3 listed)
- Controindications to MRI
- Severe comorbidities that limit the performance of MRI and TPUS
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A multicentric prospective observational longitudinal cohort study.Observational study on the accuracy of TPUS and MRI in the investigation of perianal fistulae in CD patients. | Other | – |
Primary outcome
Incidence rate of perianal fistulae through the MAGNIFI-CD index (by TPUS) and the standard MAGNIFI-CD index (by MRI)
Time frame: 1 year
To compare the accuracy of the TPUS versus pelvic MRI in assessing perianal fistulae in CD patients. Accuracy is defined as the ability to identify perianal fistulae
1 secondary outcome
Rate of fistula closure, determined by the clinician, at 12 months.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariangela Allocca principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Perianal Fistula, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIANGELA ALLOCCA (0226432069, allocca.mariangela@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of perianal fistulae through the MAGNIFI-CD index (by TPUS) and the standard MAGNIFI-CD index (by MRI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.