Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721794
Status:
RECRUITING
Last Update Posted:
2023-02-10
First Post:
2023-01-27
Brief Title:
Comparative Accuracy of Transperineal Ultrasound TPUS Versus Magnetic Resonance Imaging MRI for the Assessment of Perianal Fistulae in Patients With Crohns Disease CD a Prospective Observational Longitudinal Cohort Study
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Comparative Accuracy of Transperineal Ultrasound TPUS Versus Magnetic Resonance Imaging MRI for the Assessment of Perianal Fistulae in Patients With Crohns Disease CD a Prospective Observational Longitudinal Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPUS-MRI
Brief Summary:
Crohns 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 Crohns 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 eg 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 eg medical andor 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-CD6 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
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 eg 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 eg medical andor 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-CD6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None