Crohn Disease Clinical Trial
Official title:
Characterization of Crohn's Disease at Confocal Laser Endomicroscopy and Related to Disease Activity
A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease.
Introduction: Crohn's disease is a well-characterized disease, and treatment is carried out
according to international guidelines. Despite this, the disease often show an individual,
unpredictable course, and more than half of patients experience significant complications of
the disease. Endoscopy is important for the assessment of disease dissemination and severity
of Crohn's disease, which is complemented by biochemical and clinical indices, including
CDAI or Simple Index (SI) (Harwey-Bradshaw), which is internationally recognized. By CDAI,
there is shown a good correlation with the biochemical activity markers such as CRP, and
serum albumin, and in practice the simplified version (SI). Is often used.
Knowledge about the use of CLE in Crohn's disease is very low. We will on the basis of
parameters suggested in smaller studies and our personal CLE experience determine which
parameters are useful for a precise estimation of the severity of Crohn's disease. Since the
disease is most commonly seen in the terminal ileum, the parameters should apply to both the
ileum and colon.
A group Crohn patients have long been in prolonged biochemical and conventional endoscopic
remission, including patients treated with the biologic drug infliximab. These patients are
also included in the study as a particularly interesting subgroup as CLE in a small study
has suggested to contribute to the safe discontinuation of immunosuppressive therapy. The
degree of healing of the mucous membrane including an intact barrier function is one of the
most important prognostic factors for patients to develop a recurrence. Thus it will be of
great clinical importance to clarify whether CLE can help to distinguish those patients who
have an apparently normal endoscopy, yet unrealized discrete activity and defective barrier
function from patients where there is no activity evaluated endoscopically and by CLE.
Furthermore, a small number of patients will be included as a control group.
Hypothesis: CLE can characterize Crohn's disease and activity precisely in the ileum and
colon compared with conventional ileocolonoscopy, including detecting slight degrees and
wider dissemination of inflammation that would otherwise not be recognized.
Design: A blinded prospective observation and method study of patients with subsequent
calculation of intra-and inter-observer variability.
Method: The patients enrolled including the control group, will be investigated
respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The
degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE
(selected parameters) and histology biopsies. Terminal ileum and each colonic segment
(caecum, ascending colon, transversal colon, descending colon, colon sigmoid and rectum) are
assessed as described above. Then, the correlation between histology (gold standard), SI and
CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3
observers are blinded with respect to each other. The pathologist is blinded to conventional
and CLE parameters. CLE results are stratified in order to identify which of the recorded
CLE parameters that correlate best with the two other methods, and thus are most suitable
for the characterization and activity of Crohn's disease.
Statistical method: To calculate the CLE-finding in relation to respectively, SI and
histology we use Spearman correlation analysis. At the inter-and intra-observer study used
weighted Kappa.
Patient: A complete sample-size calculation has been made for the inter-and intra-observer
study of the individual CLE parameters by 3 observers. For, if possible, to achieve a kappa
value of 0.9 with a confidence interval of 0.05, there must be 122 observations. If we
succeed in registering SI score, CLE parameters and taking tissue samples for pathology in
all the above intestinal segments, there will be 7 observations for each patient who
subsequently are assessed in relation to each of the parameters used in the study. If all
ileocolonoscopy are completed and all CLE observations are possible to analyze just 18
patients need to be enrolled in the study. It is assumed, however, that there will only be
50% of the expected observations as some CLE observations will be unsatisfactory and some
procedures will be interrupted. Thus, 36 patients shall be included in the study to achieve
the desired strength, 10 of which are in the control group.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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