Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06056986 |
| Other study ID # |
3310 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 18, 2020 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Maria Assunta Zocco |
| Phone |
00393470597805 |
| Email |
mariaassunta.zocco[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The choice of the optimal timing for surgery in Crohn's disease is a challenging issue and
diagnostic tools able to estimate the degree of fibrosis are of great interest in this
context. Indeed, inflammatory intestinal loops are more likely to respond to medical
therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography,
which is a non-invasive and largely available technique for the study of tissue elasticity,
is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs
histologic examination in patients with stenosing Crohn's disease, showing encouraging
results.
Aim of this study is to evaluate the diagnostic agreement between elastographic parameters
(mean, median, stability index) and the degree of intestinal fibrosis evaluated on the
surgical specimen.
Description:
Background: The choice of the optimal timing for surgery in Crohn's disease is a challenging
issue and diagnostic tools able to estimate the degree of fibrosis are of great interest in
this context. Indeed, inflammatory intestinal loops are more likely to respond to medical
therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography,
which is a non-invasive and largely available technique for the study of tissue elasticity,
is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs
histologic examination in patients with stenosing Crohn's disease, showing encouraging
results.
Primary aim: to evaluate the diagnostic agreement between elastographic parameters (mean,
median, stability index) and the degree of intestinal fibrosis evaluated on the surgical
specimen.
Secondary aims:
- To evaluate the relationship between clinical disease activity assessed by the Harvey
Bradshaw index and elastographic parameters.
- To evaluate the concordance between three different methods of shear wave elastography
(point and 2D) and different machines.
- To identify elastographic cut-offs capable of predicting the presence and degree of
fibrosis.
- To evaluate the agreement between elastography and magnetic resonance imaging (MRI)
parameters of fibrosis in a subgroup of patients who underwent MRI preoperatively.
Exploratory aims:
- To evaluate the relationship between elastographic parameters/fibrosis histological
score and serum fibrosis biomarkers.
- To evaluate the relationship between elastographic parameters/fibrosis histological
score and fecal microbiota.
- To evaluate the changes in serum biomarkers of fibrosis assayed pre- and
post-operatively.
- To evaluate the changes in fecal microbiota analyzed pre-and post-operatively Study
design: Prospective, interventional, single-center study Methods: Consecutive patients
with ileal or ileo-colonic Crohn's disease needing to undergo ileo-cecal resection as
per clinical practice with an affected intestinal segment detectable in B-mode
ultrasound will be enrolled in the Unit of Internal Medicine and Gastroenterology of the
Policlinico Gemelli. Exclusion criteria will be diagnosis of IBD other than Crohn's
disease, Crohn's disease without ileal involment, lack of visualization of affected
intestinal tract (eg. obesity), hearth failure, known allergy to ultrasound contrast
agents, pregnancy and lactation. Considering that the primary objective is the
evaluation of the agreement between the parameters obtained from three different
elastography and the degree of intestinal fibrosis evaluated on the surgical specimen
(histological) and assuming that the disagreement rate (for each single comparison) is
5%, with a confidence level of 0.05 and a power of 80%, a sample size of N=18 subjects
is proposed. Upon informed consent, personal data and anamnesis will be collected within
30 days from the scheduled date for surgery (T0) and a venipuncture will be carried out
as per normal clinical practice. Subsequently we will proceed with the ultrasound
evaluation in B-mode for the identification of the target loop and the elastographic
examination with two different ultrasounds (Esaote - MyLabTM9 and Aixplorer Mach 30® -
SuperSonic Imagine) and three different technologies (point and 2D Esaote QElaxto ® and
ShearWave™ Elastography-Supersonic Imagine). After surgical intervention, fibrosis
scores will be calculated on the target loop by an expert Anatomo-Pathologist. Blood
tests, ultrasound evaluations (B-mode ultrasound, elastography), surgery and
histological examination of the intestinal specimen will be performed as per normal
clinical practice. Data obtained from these procedures will be recorded and analyzed
specifically for the study. The only study-specific procedures are the collection of
fecal samples for microbiota evaluation, urine samples for metabolomics evaluation and
an additional blood sample for evaluation of fibrosis biomarkers, all collected at T0
and 6-8 weeks after surgery (T1). The additional blood sample will be taken from the
same peripheral venous access route used for blood sampling in normal clinical practice.
