Crohn's DiseaseNCT07555808
MRI-Based Screening in a Retrospective Cohort Reveals Adverse Prognosis of Asymptomatic Perianal Fistulas in Crohn's Disease: A Long-term Follow-Up Study
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
The goal of this observational study is to learn about the necessity of imaging screening for perianal fistula in Crohn's disease (CD) patients without perianal symptoms by comparing the natural history and long-term outcomes between those with asymptomatic perianal fistula (APF) and those with symptomatic perianal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn's Disease
- How many people
- 669 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 1 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: the CD patients diagnosed between January 1, 2010, and December 31, 2019, enrolled from the prospective CD database in our IBD center, who also had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis. Those with incomplete records or less than 5 years of follow-up were excluded. Patients were classified into the APF group or the symptomatic perianal fistulizing Crohn's disease (PFCD) group (control) based on the presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery).
Who may be able to join
- CD patients diagnosed between January 1, 2010, and December 31, 2019;
- had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis;
- prospective follow-up in our IBD center;
Who cannot join
- with incomplete records;
- less than 5 years of follow-up;
About this study
Official title: Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
The goal of this observational study is to learn about the necessity of imaging screening for perianal fistula in Crohn's disease (CD) patients without perianal symptoms by comparing the natural history and long-term outcomes between those with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistulizing Crohn's disease (PFCD).
The main questions it aims to answer are:
Read more
Does the early detection of asymptomatic perianal fistula through routine MRI screening lead to a better long-term prognosis in CD patients?
How do the clinical courses and long-term outcomes compare between CD patients with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistula (PFCD)?
In accordance with our center's standard operating procedure (SOP), all patients with suspected CD underwent perianal MRI, regardless of perianal symptoms. Participants were retrospectively enrolled into a dedicated CD cohort at our center between 2010 and 2019. For this study, patients from this cohort who were diagnosed with perianal fistula at initial diagnosis will be retrospectively assessed. They were initially classified into the APF group or the symptomatic PFCD (control) group based on the presence of perianal symptoms at diagnosis. Using advanced statistical methods, the study will compare the risks of major disease complications, treatment initiation patterns, and overall disease progression between these two groups over years of follow-up.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, asymptomatic perianal fistula, perianal magnetic resonance imaging
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic perianal fistula group | pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; absence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery) | |
| symptomatic perianal fistulizing Crohn's disease (PFCD) group | pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD-related intestinal surgery
CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
Secondary outcomes (4)
intestinal stricture
A diagnosis of intestinal stricture is established if it meets either of the following criteria: (1) Imaging criteria: the narrowed segment exhibits at least two of these three features compared to the adjacent proximal bowel segment: >50% reduction in lumen diameter, >25% increase in bowel wall thickness, or pre-stricture dilation >3 cm; or (2) Endoscopic criterion: the stricture is impassable to the endoscope.The onset of a CD-related intestinal stricture was defined as the time point when it was first detected on imaging during follow-up.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
intestinal fistula
An intestinal fistula is defined as an abnormal communication between bowel loops or between the bowel and other organs, identified on imaging. The onset of a CD-related intestinal fistula was defined as the time point when it was first detected on imaging during follow-up.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
Medically difficult-to-treat status
Medically difficult-to-treat status was defined according to the IOIBD criteria as the failure of at least two biologic or small-molecule agents with different mechanisms of action. The date of initiating a third mechanism-of-action agent was used as the time of diagnosis for medically difficult-to-treat status.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
clinically prioritized composite endpoint
Given that the outcome events were multidimensional and differed in clinical importance, the conventional composite endpoint approach was deemed inappropriate; therefore, win ratio method was adopted. The events were prioritized in descending order of clinical importance as follows: CD-related intestinal surgery > intestinal fistula > intestinal stricture > medically difficult-to-treat CD. Because the presence of perianal symptoms is the direct indication for perianal surgery, perianal surgical events were not included in the prioritized composite outcome to avoid reverse causality. This priority order was determined based on clinical practice. To mitigate potential bias introduced by a fixed priority order, sensitivity analyses were performed using alternative orderings.
Measured: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555808
- Sponsor's protocol ID
- E2025277
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
- ClinicalTrials.gov ID
- NCT07555808
- Acronym / sponsor ID
- E2025277
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, asymptomatic perianal fistula, perianal magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 29 Apr 2026 (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.
The goal of this observational study is to learn about the necessity of imaging screening for perianal fistula in Crohn's disease (CD) patients without perianal symptoms by comparing the natural history and long-term outcomes between those with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistulizing Crohn's disease (PFCD).
The main questions it aims to answer are:
Does the early detection of asymptomatic perianal fistula through routine MRI screening lead to a better long-term prognosis in CD patients?
How do the clinical courses and long-term outcomes compare between CD patients with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistula (PFCD)?
In accordance with our center's standard operating procedure (SOP), all patients with suspected CD underwent perianal MRI, regardless of perianal symptoms. Participants were retrospectively enrolled into a dedicated CD cohort at our center between 2010 and 2019. For this study, patients from this cohort who were diagnosed with perianal fistula at initial diagnosis will be retrospectively assessed. They were initially classified into the APF group or the symptomatic PFCD (control) group based on the presence of perianal symptoms at diagnosis. Using advanced statistical methods, the study will compare the risks of major disease complications, treatment initiation patterns, and overall disease progression between these two groups over years of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic perianal fistula group | – | –pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; absence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery) |
| symptomatic perianal fistulizing Crohn's disease (PFCD) group | – | –pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the CD patients diagnosed between January 1, 2010, and December 31, 2019, enrolled from the prospective CD database in our IBD center, who also had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis. Those with incomplete records or less than 5 years of follow-up were excluded. Patients were classified into the APF group or the symptomatic perianal fistulizing Crohn's disease (PFCD) group (control) based on the presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery).
Key inclusion criteria (3 listed)
- CD patients diagnosed between January 1, 2010, and December 31, 2019;
- had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis;
- prospective follow-up in our IBD center;
Key exclusion criteria (2 listed)
- with incomplete records;
- less than 5 years of follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CD-related intestinal surgery
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.
4 secondary outcomes
intestinal stricture
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
intestinal fistula
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
Medically difficult-to-treat status
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
clinically prioritized composite endpoint
Time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD-related intestinal surgery (time frame: Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.). 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 29 Apr 2026.