Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05721794 |
| Other study ID # |
TPUS-MRI |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
June 6, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
IRCCS San Raffaele |
| Contact |
MARIANGELA ALLOCCA |
| Phone |
0226432069 |
| Email |
allocca.mariangela[@]hsr.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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
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:
1. Identify 50 CD patients with perianal fistulae. Those patients will undergo both
standard pelvic MRI and TPUS.
2. Treat all patients with perianal fistulae according to international guidelines (e.g.,
medical and/or surgical treatment).
3. 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.
