NCT07555808Completed
MRI-Based Screening in a Retrospective Cohort Reveals Adverse Prognosis of Asymptomatic Perianal Fistulas in Crohn's Disease: A Long-term Follow-Up Study
Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 669 (actual)
- First submitted
- 24 Feb 2026
- Start date
- 1 Jan 2010
- Primary completion date
- 31 Dec 2019
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Crohn's disease
- NCT number
- NCT07555808
What you commit to
- Study type: Observational
- Participants enrolled: 669
- From 1 Jan 2010 to the primary completion date, 31 Dec 2019
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- with incomplete records;
- less than 5 years of follow-up;
Who the study is looking for
- 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;
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.